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NAT I O N A L A S S O C I AT I O N O F B O A R D S O F P H A R M A CY
A I D T O G O V E R N M E N T
– T H E
P R O F E S S I O N – T H E
P U B L I C – 1 9 0 4
TO
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NABP Begins Transmitting Disciplinary Information to HIPDB
Reporting to the Healthcare
the data entry module was
month’s activities, as well as a
Integrity and Protection Data
given to the boards pre-loaded
comprehensive summary of
Bank (HIPDB) is now an easy,
with disciplinary information
activity from all reporting
seamless process for those state
dating back to 1982. As state
states.
boards that choose to use NABP
boards receive disciplinary
as an authorized reporting
action information, it is
agent. NABP recently completed
entered into the Data Entry
the Disciplinary Clearinghouse
Module. Pop-up windows and
Data Entry Module, and has
pick lists help users navigate
successfully transmitted data
the program, and each month
to HIPDB.
the board e-mails the file to
As part of the advanced clearinghouse program, NABP
created the Disciplinary Clearinghouse Data Entry Module,
an Access-based software
program, for participating
member boards. Simple to use,
NABP. From this file, NABP
updates the Disciplinary
Clearinghouse records, con-
“To avoid hardship on the state
boards of pharmacy, NABP
developed the Data Entry
Module to be user friendly and
to accommodate reporting of
disciplinary action to the NABP
Clearinghouse and HIPDB,”
says Jerry Moore, NABP
president.
verts the data into the required
NABP began working on the
format and sends the informa-
software program for reporting
tion to the HIPDB. Each
disciplinary actions last
participating state board
summer. Participating state
receives a report of its previous
(continued on page 82)
83
International VIPPS Program
to be Launched by NABP
87
NABP’s VIPPS Elected
to ASAE “Honor Role”
88
The Prescription Drug
Marketing Act: Final Regulations
NABP Completes Build-out
90
NABP Completes
Headquarters Remodeling Project
ION OF BOA
AT
R
CI
DS
PHARM
OF
AC
Y
TIONAL ASS
O
NA
The remodeling of NABP’s first level, including the addition of three
managerial offices, 15 staff cubicles, and a file room, was completed
in mid-June. See story on page 90.
19 0 4
®
VOLUME 29 - NUMBER 6 - JUNE/JULY 2000
in this issue
NABP Begins Transmitting Disciplinary Information to HIPDB
(continued from page 81)
boards received and installed
module are umbrella boards. In
actions taken against health
the Data Entry Module (the
these cases, disciplinary action
care providers, suppliers, and
software program for reporting)
reporting is usually done by an
practitioners. Federal and state
in January and February 2000,
agency other than the board of
agencies and health plans are
and NABP began routine
pharmacy.
required to report to the data
transmissions of data to
HIPDB in March 2000.
“We try very hard to accommodate the boards regarding what
bank, and are permitted access
to the system for a fee. Health
care suppliers, providers, and
The Data Entry Module does
information they give us and
not require the boards to have
how they are able to provide it
the full Access software pro-
to us,” notes Moore. “If a state
gram on their computer system.
board is required to submit
Though some functions are
information directly to the
limited, the run-time version
HIPDB, we will accept a hard
(Access Light) accepts all
copy of disciplinary informa-
information required by HIPDB
tion as a submission to NABP’s
For more information or to
and the NABP Clearinghouse.
clearinghouse; and the data
make NABP your board’s
NABP staff works with each
will be entered manually by
reporting agent, contact Glenn
state to create a version that
NABP staff.”
Detweiler, Licensure Applica-
HIPDB was developed by the
Currently, 24 states have
US Department of Health and
received, and are using, the
Human Services to create a
software, which is provided at
comprehensive data collection
no charge. Most of those states
program for the reporting and
who are not using NABP’s data
disclosing of most final adverse
Representatives of eGovNet
team continues to work with
presented the RAP system to
eGovNet.com, a provider of
the executive officers and
Web-based solutions for online
members of the state boards of
transactions, to customize the
pharmacy at a special session
Renewal and
during NABP’s Annual
Application
Meeting in May 2000.
Process
Once completed, the
(RAP) system
system will allow
for each
pharmacists and
participating
pharmacies to submit
state board.
their initial licensure
Since each
application and
board’s database systems are
renewal via the Internet. When
unique, their link to the RAP
fully operational, NABP’s RAP
system must be refined to
system will feature credit and
produce an effective end result.
debit card payment for fees, and
The analysis and creation of
provide licensees with easy
each link is going smoothly,
access to their professional
and the project is moving along
information on file with partici-
as planned.
pating boards of pharmacy.
82
ary Reporting to National Data
Bank” in the January 1999
NABP Newsletter).
tion Database Programs
Director, by telephone at
847/698-6227, or by e-mail,
[email protected].
ION OF BOA
AT
R
CI
PHARM
OF
AC
Y
NABP’s Information Technology
Proposes Mandatory Disciplin-
DS
Renewal and Application Process Update
to “self-query” (see “HHS
TIONAL ASS
O
NA
meets all the state’s needs.
practitioners are only allowed
19 0 4
®
The NABP Newsletter
(ISSN 0027-5700) is published ten times
a year by the National Association of
Boards of Pharmacy (NABP) to educate,
to inform, and to communicate the
objectives and programs of the
Association and its 68 member boards of
pharmacy to the profession and the
public. The opinions and views
expressed in this publication do not
necessarily reflect the official views,
opinions, or policies of NABP or any
board unless expressly so stated. The
subscription rate is $35 per year.
National Association of
Boards of Pharmacy
700 Busse Highway
Park Ridge, Illinois 60068
847/698-6227
www.nabp.net
[email protected]
Carmen A. Catizone
Executive Director/Secretary
Mark E. Paulson
Editorial Manager
© 2000 National Association of Boards of
Pharmacy. All rights reserved. No part of this
publication may be reproduced in any manner
without the written permission of the Executive
Director/Secretary of the National Association of
Boards of Pharmacy.
NABP
NEWSLETTER
International VIPPS Program to be Launched by NABP
In order to help
meet the growing threat
endorsed a plan to
work with the
licensing authori-
Practice Sites™ (VIPPS™)
program, the new International VIPPS program will
ties in partici-
utilize the same core criteria
rogue
pating foreign
and policies to certify candi-
Internet
countries to
date Web sites. However, the
certify online
review of relevant licensure,
posed by
pharmacy
sites operating from
outside the United
States, the Association’s
Executive Committee has
pharmacies
located within their
jurisdictions.
Based on NABP’s successful
Verified Internet Pharmacy
site inspections, and other
criteria verification performed
by NABP in the US will be
conducted by the participating
foreign licensing authority.
(continued on page 95)
Fee Increase for NAPLEX, MPJE, Licensure
Transfer Effective January 1
In 1999, the NABP Executive
Also effective January 2001,
Committee approved fee
the fee for processing a Pre-
increases for the NAPLEX®
liminary Application for
(North American Pharmacist
Pharmaceutic Licensure
Licensure Examination™), the
Transfer will increase from
Multistate Pharmacy Jurispru-
$250 to $300 per state for the
dence Examination™
first state to which the appli-
(MPJE™), and transfer of
cant is requesting licensure
pharmaceutic licensure.
transfer. This increase is the
Effective January 1, 2001,
candidates sitting for the
NAPLEX and MPJE will be
required to pay an additional
administrative fee. The administrative fee for the NAPLEX
first since 1996, when the
Electronic Licensure Transfer
Program™ (ELTP™) was implemented, and is set to absorb the
average annual cost of living
between 1996 and 2003.
NAPLEX Score
Transfer Fee
Increase
Beginning September 1,
2000, NABP will increase the
score transfer fee for the
NAPLEX® (North American
Pharmacist Licensure
Examination™) from $50 to
$75. Although the Executive
Committee approved this
increase for the Fiscal Year
beginning January 1, 2000,
NABP will not implement the
change until the beginning
of September 2000. Those
will be $110, and the adminis-
The fee to request licensure
requests received from
trative fee for the MPJE will be
transfer to additional states on
candidates postmarked after
$45. This new charge will be
the same application form as
September 1, 2000, without
implemented to offset higher
the first state will remain at
the appropriate fee adjust-
seating fees charged to NABP
$50 per state. In addition, the
ment included, will be
by the Chauncey Group
current $50 fees for changing
returned. NABP will be
International, LTD, testing
the transferring state, referred
notifying appropriate schools
vendor of both examinations.
to as Change of State, and
of pharmacy.
The base testing fees for both
the NAPLEX and MPJE are not
expected to increase for the
next several years. The NAPLEX
fee will remain $250, and the
extending the life of an Official
Application for Transfer of
Pharmaceutic Licensure,
known as Extension of Time,
will remain unchanged.
For additional information
about the NAPLEX, please
call NABP at 847/698-6227,
or visit the Association’s
Web site at www.nabp.net.
MPJE fee will stay at $85.
JUNE/JULY 2000
83
LegalBriefs
How Do You Stop a Charging Pharmacist?
By Dale Atkinson, JD
pharmacy’s records were
not adequately notify him of
Perhaps one of the
inaccurate and disorganized.
the standard for evaluating
most effective tools
The investigator recommended
compliance with the law. In
for a board of
continuing the investigation to
rejecting this argument, the
pharmacy in
the Board, and eventually
Supreme Court of New Hamp-
carrying out its
conducted an audit on the
shire cited numerous statutes
mission of public
pharmacy. Based upon this
that authorized the Board to
protection is the
audit, the Board commenced
enforce the practice act and
ability to enter an
disciplinary proceedings
provide for the protection of
administrative
against the pharmacist.
the public. Such authorization
also provided for the authority
order that prohibits or limits
The pharmacist was charged
the rights of a licensee to
with 10 counts of failing to
practice. Whether the board
maintain accurate and com-
has the authority to “limit” the
plete controlled drug records,
practice privileges of a licensee
four counts of dispensing
must be interpreted through
controlled drugs in unlawful
the practice act, which legisla-
quantities, and one count of
Incredibly, the pharmacist
tively creates and empowers the
dispensing incorrect medica-
argued that since perfect
regulatory entity. Many prac-
tion. The Board also ques-
compliance with the laws is
tice acts do not specifically
tioned the pharmacist’s
impossible, express standards
provide for the authority of the
competence, both generally and
are necessary to inform him as
board to limit the license of a
as a pharmacist-in-charge.
to what degree of noncompli-
practitioner as part of an
After a formal hearing and
ance will subject him to
administrative disciplinary
upon rehearing the matter due
penalties under applicable law.
proceeding. The following case
to a petition by the pharma-
The court quickly disposed of
provides an interesting judicial
cist, the board restricted the
this argument, stating that
analysis of board orders under
practice privileges of the
pharmacists and pharmacies
disciplinary proceedings,
pharmacist’s license by pre-
have an unequivocal duty to
including the limitation placed
cluding him from serving as a
comply with pharmacy and
upon the license of a pharma-
pharmacist-in-charge for an
drug laws. Therefore, any
cist-in-charge. Additional
indefinite period of time and
noncompliance with such laws
interesting issues involving
imposing a $1,000 fine. The
will potentially subject a
administrative searches are
pharmacist, however, was not
licensee to investigation and
also discussed.
precluded from practicing
prosecution. The court contin-
A pharmacist duly licensed in
pharmacy in a capacity other
ued, stating that while perfect
New Hampshire purchased a
than as a pharmacist-in-charge.
compliance may not be pos-
pharmacy. Thereafter, he
The pharmacist appealed the
became the pharmacist-in-
ruling of the Board on numer-
charge under the applicable
ous grounds. First, the phar-
statute. While visiting the
macist contended that the
pharmacy in the course of an
statutes governing the Board’s
unrelated matter, a New
authority and procedures to
Hampshire Board investigator
inspect pharmacy were imper-
observed that a number of the
missibly vague because they did
84
of the Board, or its designated
representatives, to enter
pharmacies and investigate
possible violations of applicable laws.
sible, decisions to investigate
and prosecute are committed
to the sound discretion of the
Board. By virtue of its specialized knowledge and authority,
the Board alone is empowered
to develop enforcement policies
best calculated to achieve the
NABP
NEWSLETTER
ends contemplated by the
accurate records of sales of
Finally, and because access is
Legislature and must allocate
certain drugs. Thus, the state
limited to normal business
available funds and personnel
clearly has a recognized
hours and to original records or
in a way to execute these
substantial interest in regulat-
prescriptions, the statutory
policies effectively and
ing the sale and distribution of
scheme is sufficiently limited in
efficiently.
drugs to deter their illicit use
time, place, and scope as to
whenever possible and trace
constitute an adequate substi-
their movement through the
tute for a warrant. Based upon
channels of commerce.
the foregoing, the court held
The pharmacist next argued
that the audit conducted by
the Board constituted an
that the audit was lawfully
illegal administrative search
under the federal and state
constitutions. In addressing
these arguments, the court
first stated the general rule
that absent a recognized
exception, a warrantless search
by a government body is, per
se, unreasonable and invalid.
However, New Hampshire has
explicitly recognized an administrative search exception. In
order to satisfy this exception,
three criteria must be met:
1.
There must be a
substantial government
Incredibly, the
pharmacist argued that
since perfect
compliance with the
laws is impossible,
express standards are
necessary to inform him
as to what degree of
noncompliance will
subject him to penalties
under applicable law.
Next, the licensee argued that
the Board disclosed the contents of prescriptions during
the proceedings in violation of
applicable confidentiality
statutes. Such statutes prohibit Board officials or representatives from divulging
prescription orders and records
inspected in the course of their
duties “except in connection
with a prosecution or adminislicensing board to which
prosecution or proceeding of
ment, requiring a warrant
the person to whom such
before inspection would impede
prescriptions, orders or records
The warrantless
the abilities of the inspectors
relate is a party.” The pharma-
inspection must be
to deter faulty records and
cist argued that the person to
necessary to further the
illegal dispensation of drugs.
whom such prescriptions
regulatory scheme; and
Requiring a warrant would also
“relate” refers to the customer,
The implementation of
inhibit the ability of the Board
and therefore the customer’s
the statutory inspec-
to quickly investigate wrongdo-
consent must be obtained
tion program must
ing that may pose a threat to
before the prescriptions can be
provide a constitution-
public safety. Accordingly,
disclosed during the disciplin-
ally adequate substi-
warrantless access to records is
ary hearings. The court de-
tute for a warrant.
necessary to ensure that the
clined to accept this argument
inspection is made;
3.
administrative proceedings.
Addressing the second require-
pursuant to which the
2.
uncovered was admissible in the
trative proceeding before a
interest that informs
the regulatory scheme
conducted, and the information
mere prospect of inspections
based upon the unreasonable
Regarding the first require-
will prompt otherwise ques-
result that could occur when
ment, New Hampshire has long
tionable licensees to comply
the pharmacist and customer
required pharmacists to keep
with the law.
act in concert and refuse to
authorize disclosure.
(continued on page 86)
JUNE/JULY 2000
85
NABP Awards
VIPPS Certification
to Tel-Drug Rx
Tel-Drug Rx®, of Sioux Falls,
SD, a wholly-owned subsidiary of CIGNA HealthCare
and located at
Finally, the licensee argued
case and, thus, the court
that there was no evidence
would not substitute its
presented that he personally
judgment for that of the Board
failed to enter data which
under these circumstances.
gave rise to the current
Based upon the foregoing, the
charges. In effect, the phar-
court upheld the sanction
macist argued that he could
imposed upon the licensee.
not be personally responsible
www.teldrug.com, has
for the alleged wrongdoings.
become the most recent
The court rejected this
online pharmacy to receive
argument, stating that the
the Verified Internet Phar™
LegalBriefs (continued from page 85)
™
macy Practice Sites (VIPPS )
certification from NABP.
licensee was the pharmacistin-charge and responsible for
the practice of pharmacy in
and by that pharmacy,
including, but not limited to,
compliance with all local,
state, and federal pharmacy
and drug laws. Hence, the
licensee’s status as a pharmacist-in-charge imposed upon
Boards of pharmacy must be
aware of the legislative authority that empowers the regulatory agency to investigate and
discipline licensees. Understanding the relationship of
the investigative process to the
eventual sanction should
wrongdoing be substantiated is
essential in avoiding appeals
and ultimately protecting the
public. Board members and
inspectors must understand
the necessity of and process for
Tel-Drug Rx is a mail order
him heightened responsibili-
pharmacy program offered by
ties under the law compared
Tel-Drug, Inc, especially for
to those imposed on a phar-
maintenance medications
macist. Related to this
prescribed for long-term
argument, the licensee argued
treatment of chronic condi-
that indefinitely prohibiting
tions. Tel-Drug Rx also
him from serving as a phar-
provides toll-free customer
macist-in-charge unfairly and
service and 24-hour refill
disproportionately imposed a
ordering and emergency
sanction in violation of the
pharmacy services.
state constitution.
Participation in the VIPPS
Recognizing that the licensee
macist-in-charge while
certification program is
was able to continue practic-
allowing the authority to
voluntary. The program was
ing pharmacy and was also
continue the practice generally.
developed to provide consum-
able to petition the Board
From a practical standpoint,
ers with reliable means to
anytime to lift the restriction
boards which limit the practice
identify those online pharma-
upon a showing that he is
privileges of a licensee must
cies that have proven their
capable of assuming the
also be prepared to monitor
ability and authorization to
duties of a pharmacist-in-
and enforce such limitations.
dispense pharmaceuticals to
charge, the court rejected the
the public in the jurisdictions
arguments of the pharmacist.
listed on the VIPPS Web site.
Applying appropriate deference
For more information about
to the decision of the Board,
Attorney Dale J. Atkinson is a
the VIPPS program, call
the court recognized that
partner in the law firm of
NABP at 847/698-6227 or go
sanctions are necessarily
Atkinson & Atkinson, counsel for
to NABP’s Web site at
tailored to the facts of each
NABP.
obtaining a warrant prior to
performing inspections. Boards
must also understand their
authority in crafting an
appropriate sanction under
certain circumstances. Interestingly, this opinion did not
address the authority of the
board to “limit” a license, and
in this case, prohibit a practitioner from acting as a phar-
Appeal of William H. Morgan,
RPh 742 A.2d 101 (NH 1999).
www.nabp.net.
86
NABP
NEWSLETTER
Professional AffairsUpdate
HRSA Announces Clinical
Pharmacy Initiative
ethnic and racial groups,” states
nology tools by 2003 to help
Dr Marilyn Gaston, HRSA’s
prevent medication errors
Associate Administrator for
resulting from poorly handwrit-
The US Health Resources and
Primary Health Care. “A clinical
ten prescriptions. The paper,
Services Administration’s
pharmacist is a key member of a
entitled “A Call to Action:
(HRSA) Bureau of Primary
health delivery team. In addi-
Health Care (BPHC) recently
tion to dispensing drugs, the
announced its Clinical Phar-
pharmacist consults with
macy Initiative, a program that
patients, monitors their use of
emphasizes clinical pharmacy
prescribed drugs, and checks for
services as a necessary part of
potential drug interactions. A
the delivery of primary health
clinical pharmacist prevents
care. HRSA is the agency
problems caused by drug
within the US Department of
interactions, inappropriate
Health and Human Services
doses, and failure to adhere to
responsible for improving
the prescribed therapy.”
access to health care. Through
the Clinical Pharmacy Initia-
For more information on OPA
tive, the BPHC’s Office of
activities, visit their web site at
Pharmacy Affairs (OPA) will
www.hrsa.gov/odpp.
develop working relationships
ISMP Calls for Elimination
of Handwritten Rxs
with BPHC programs to help
them implement and maintain
clinical pharmacy services.
“The Initiative’s emphasis on
comprehensive pharmacy
services is consistent with
HRSA’s strategy for achieving
100% access to health care and
zero health disparities among
Eliminate Handwritten Prescriptions Within 3 Years,” is
the first in a series of “White
Papers” planned by ISMP to
address the topic of medication
errors. It describes the benefits,
drawbacks, costs, and techno-
The Institute for Safe Medica-
logical considerations of using
tion Practices (ISMP) has
this kind of technology
published a discussion paper
to address medication errors.
that calls for the elimination of
handwritten prescriptions and
advocates the widespread use
of handheld prescribing tech-
“Technology can’t solve all the
medication error problems in
the world,” states ISMP President Michael R. Cohen, MS.
“In fact, we often see that
NABP’s VIPPS Elected to ASAE “Honor Roll”
technology can actually
introduce a whole new set of
problems if we don’t use it
NABP has been elected to
efforts to inform consumers
the Associations Advance
about those online pharma-
America Honor Roll, a
cies that have met the
national awards competition
rigorous 17-point VIPPS
sponsored by the American
criteria, and are in compli-
Society of Association
ance with the licensure laws
Executives (ASAE), Washing-
of the jurisdictions in which
ton, DC, in recognition
they practice pharmacy. By
of its Verified Internet
clicking on the VIPPS seal
Pharmacy Practice Sites™
found on the home pages of
(VIPPS™) program.
program-certified online
The document is available on
pharmacies, consumers are
ISMP’s Web site at
instantly hyperlinked to
(continued on page 92)
www.ismp.org.
Specifically, ASAE recognized
NABP’s VIPPS program for its
JUNE/JULY 2000
appropriately. Still with proper
systems design, implementation, and maintenance, the
benefits of handheld prescribing far outweigh the drawbacks. There’s simply no good
reason why we can’t begin
using this technology now to
make prescribing a lot safer.”
87
The Prescription Drug Marketing Act: Final Regulations
Editor’s Note: Following is a
composed wholly or partially of
of the charity, or by
special column, submitted by
insulin, whether prescription
personal delivery by the
the US Food and Drug Adminis-
or over-the-counter (OTC), are
donor. Samples must
tration, to further explain final
subject to the reimportation
be placed in a sealed
regulations concerning the
restrictions of section 801(d) of
carton by the donor for
Prescription Drug Marketing Act
the Federal Food, Drug, and
delivery to or collection
(PDMA).
Cosmetic Act (the Act). Section
by the recipient charity.
The final regulations implementing the Prescription Drug
Marketing Act (PDMA) amendments to the Federal Food,
Drug, and Cosmetic Act were
published in the December 3,
1999 Federal Register (Docket
Nos. 92N-0297 and 88N-0258).
The regulations become final
December 4, 2000.
The final rule covers:
801(d) of the Act prohibits the
reimportation of any prescription drug that was originally
manufactured in the United
States back into the US unless
the importation is by the
manufacturer of the drug or, in
the case of a medical emergency, with the permission of
the FDA.
Drug Donation of Samples
(3) A donated sample
cannot be dispensed to
a patient or be distributed to another charitable institution until
it has been examined
by a licensed practitioner or registered
pharmacist at the
recipient charity to
confirm that the
donation record
Prescription drug samples may
accurately describes the
wholesale distribution
be donated provided there is
drug sample delivered,
of prescription (Rx)
accountability and oversight of
and that the drug
drugs;
such donations that will serve
sample is not adulter-
to minimize the potential for
ated or misbranded for
diversion of the samples. Even
any reason.
(1) the reimportation and
(2) the distribution of Rx
drugs purchased by
hospitals or other
health care entities;
(3) drugs donated to
though no comments were
received on this section in the
proposed rule (F.R. Vol. 59, No.
49, March 14, 1994), several of
charitable organiza-
the proposed requirements
tions;
have been eliminated as too
(4) the distribution of Rx
drug samples; and
(5) certain sections of the
“Guidelines for State
Licensing of Wholesale
Prescription Drug
Distributors” (21 CFR
Part 205).
Reimportation
burdensome. Prescription drug
samples may be donated
provided the following rules are
observed:
(4) The recipient charity
must dispose of any
drug sample found to
be unsuitable by
destroying it or returning it to the manufacturer for destruction.
The charity shall
maintain complete
records of the disposi-
(1) Donated drug samples
are packaged in their
tion of all destroyed or
returned samples.
original, unopened
packaging with intact
labeling.
(5) The recipient must
prepare a complete and
accurate donation
(2) Donated drug samples
record at the time of
The reimportation section of
may be delivered by
the collection or
the PDMA was amended by the
mail or common carrier
delivery of the drug
US Food and Drug Administra-
to the recipient chari-
samples. A copy of this
tion (FDA) Modernization Act
table organization,
donation record must
to include drugs composed
collected by an autho-
be kept for at least
wholly or partially of insulin.
rized agent or employee
three years.
Therefore, drug products
88
NABP
NEWSLETTER
(6) Each recipient must
(3) unsuitable drugs are
keep complete and
destroyed or returned
accurate records of
to the supplier for
drug sample donation
destruction; and
sufficient for complete
accountability and
(4) there are adequate
may be used in place of paper
records to comply with PDMA.
Paper Records
Part 11 does not apply to paper
inventory, accountabil-
records that are transmitted by
ity, and security
electronic means, such as
systems to prevent loss,
faxing. Since Part 11 does not
theft, or diversion of
apply to paper documents that
conduct, at least
the donated drugs. For
are photocopied, microfiched,
annually, an inventory
the FDA, the bottom
or faxed, the final regulations
of prescription drug
line on donations is
contain revised security and
sample stocks and
that if a drug cannot
authentication requirements
prepare a report
be sold in the United
for paper records.
reconciling the results
States, it cannot be
of each inventory with
donated. The Agency
Mid-Level Practitioners
the most recent prior
advises that previously
When there is a question
inventory.
dispensed prescription
concerning whether a mid-level
drugs may not be
practitioner may request,
donated. In addition,
receive, or dispense prescrip-
since such donation is
tion drug samples, one must
distribution of a
look to the laws of the state
auditing of drug
sample stocks.
(7) Each recipient must
(8) Drug samples must be
stored under appropriate conditions.
(9) A recipient shall notify
prescription drug to a
where the practitioner prac-
the FDA within five
party other than a
tices. It is state law that
working days of discov-
consumer or patient,
determines the practices and
ering a significant loss
the Agency considers
authorities granted to such
or known theft of
this to be wholesale
practitioners. If a mid-level
prescription drug
distribution.
practitioner is permitted to
samples.
Drug Donation of
Non-Samples
Electronic Records and
Electronic Signatures
21 CFR Part 11, Electronic
prescribe prescription drugs
but is prohibited by state law
from receiving samples, that
mid-level practitioner may not
be sampled.
Although no specific controls
Records; Electronic Signatures
are established in this regula-
(F.R. March 20, 1997) super-
tion for the donation of non-
sedes the requirements con-
sample prescription drugs, the
cerning electronic systems and
All drug shipments sent back
Agency (FDA) recommends that:
records in the proposed PDMA
to the manufacturer or supplier
regulations.
by hospitals and other health
(1) the donor verify that
care entities are categorized as
the charity is legiti-
Part 11 applies to any records
mate;
created, modified, archived,
(2) all donated drugs are
retrieved, or transmitted to the
screened by a physician
agency under all laws and
or pharmacist to
regulations administered by the
eliminate drugs that
FDA. Provided the requirements
are recalled, outdated,
of Part 11 are met, electronic
or otherwise unsuitable
records, electronic signatures,
for human use;
handwritten signatures executed to electronic records
JUNE/JULY 2000
Drug Returns
returns. A credit memo
containing information specified in the regulation must be
prepared by the hospital,
health care entity, or charitable organization, and a copy
must be sent to the manufacturer. Any drugs returned to a
manufacturer or wholesale
(continued on page 93)
89
NABP Completes Headquarters Remodeling Project
Construction of the remodeling of the first level at NABP’s
headquarters in Park Ridge, Ill,
was completed in early June.
Construction began on April
17, 2000.
“This build-out will help NABP
provide more efficient service
to the boards by centralizing
customer service and application data processing,” says
Jerry Moore, JD, RPh, NABP
president. “In the long run,
this will help NABP control
costs by using the current
Consruction workers near completion of the final phase of the
build-out. This main row of cubicles is now the home of the
Foreign Pharmacy department and Office Services.
space available to its maximum capability. As the Association continues to expand
its programs and services, this
to be the most cost-effective
construction, we are pleased
project will also allow NABP to
choice.
with the results and looking
plan for its future needs.”
“The general idea was to create
forward to moving in.”
In order to provide expanded
a suite of offices on the first
The newly transformed first
member services, NABP began
level that was as pleasant a
level includes three managerial
to explore its options to
working atmosphere as the
offices, 15 staff cubicles, and
accommodate additional staff
existing second level,” says
an updated file room. Also part
early this year. After much
Margaret Gould, NABP office
of the expansion, NABP has
consideration, remodeling the
services manager, who has
installed a new phone system.
first level of its Park Ridge
overseen the entire remodeling
Staff moved into the first level
headquarters was determined
project. “After seven weeks of
in late June.
NABP Accepting Inspector DSA Nominations
NABP is cur-
health and welfare. A
2000. Letters should be ad-
rently accepting
special luncheon will
dressed to Executive Director/
nominations for
be held to honor the
Secretary Carmen A. Catizone,
recipient of NABP’s
and should include a written
2000 DSA for Inspec-
narrative that explains why the
Hosto Distin-
tors on Monday,
nominee should be considered.
guished Service
November 13, 2000
The list of nominees will be
Award (DSA) for
during NABP’s Health
reviewed by the Executive
Inspectors. The
Law Officers Confer-
Committee.
the Association’s
2000 Lester E.
DSA
Nomination
award honors those board
compliance officers who have
been acknowledged by NABP’s
Executive Committee for their
efforts in furthering NABP’s
objectives to protect the public
90
ence in Biloxi, Miss.
Nomination letters should be
All letters of nomination for
sent to NABP headquarters at
the award must be received at
700 Busse Highway, Park
NABP headquarters no later
Ridge, IL 60068, or faxed to
than Friday, September 1,
847/698-0124.
NABP
NEWSLETTER
State
Board
News
Washington Board
that get into trouble with drugs
NABP Seeks Item
Writers for Testing
Programs
or alcohol. We send these
Pharmacy practitioners,
individuals to treatment . . .
educators, and regulators
Pharmacy is expanding its
and allow them to return to
who are interested in
definition of the legal use of
the practice of their respective
serving as an item writer for
needles and syringes to include
profession. However, we take a
the North American Phar-
the prevention of blood borne
different, less kindly, view of
macist Licensure Examina-
in the rehabilitation of the
Expands the Legal Use of
Needles and Syringes
licensed health professionals
The Washington State Board of
diseases. Although the state
other drug
tion™ (NAPLEX®), Multistate
of Washington does not
abusers, particu-
Pharmacy Jurisprudence
require a prescription to sell
larly intravenous
Examination™ (MPJE™),
syringes, they can only be
drug users. By
or the Disease State
sold for legal use.
increasing the
Management (DSM) exami-
Currently, the law in Wash-
availability of
nations should send or fax
ington states “the retailer
syringes, we have
a letter of interest and a
shall satisfy himself or
an opportunity to
current resume or curricu-
herself that the device will be
help these
lum vitae to NABP’s Execu-
used for the legal use intended.”
unfortunate individuals while
tive Director/Secretary
By redefining legal use, pharma-
preventing the overall spread
Carmen A. Catizone at 700
cists would have more legal
of disease at the same time.”
Busse Highway, Park Ridge,
discretion to sell syringes to
Many pharmacies stopped
IL 60068; fax 847/698-0124.
intravenous drug users, thus
selling needles and syringes
Item writers will receive
helping to slow the spread of
after passage of the 1998 State
training materials describ-
HIV and hepatitis.
Drug Paraphernalia Law, which
ing the skills necessary for
After reviewing the evidence
made the distribution of
their designated examina-
presented at a program spon-
needles and syringes a civil
tion, and may be asked to
sored by NABP, the Centers for
offense when they are used to
attend a weekend workshop
Disease Control and Prevention
inject illegal controlled sub-
at NABP headquarters or
(CDC), and the American
stances. An exception exists,
an area hotel, with appli-
Pharmaceutical Association
however, when injection syringe
cable expenses paid by
(APhA) in the Spring of 1999,
equipment is distributed
NABP. Item writers will
Washington State Board of
through public health and
receive periodic requests to
Pharmacy Executive Director
community-based HIV preven-
develop new test items that
Donald H. Williams drafted a
tion programs. While the
will be considered for
resolution for the Board to
exception was placed in the law
inclusion in NABP’s
consider, which is now moving
to allow needle exchange
assessment programs.
through the rulemaking
programs to continue to
process. “I believe that if the
operate, the Board recommends
Board could reinterpret the
that pharmacists use the
syringe law, we might find a way
exception to sell needles and
for our pharmacists to partici-
syringes after establishing a
pate in another public health
relationship with their local
program,” says Williams.
public health agency. Such a
relationship could be created
“I find it interesting that the
by contract or by obtaining a
boards of pharmacy, medicine,
letter of support from the
nursing, etc, are very interested
health agency.
JUNE/JULY 2000
State board of pharmacy
members and staff are
particularly encouraged to
participate in the item
writing process. Questions
about item writing should
also be directed to Carmen
A. Catizone at NABP
headquarters.
91
Expanded ELTP Training Session Offered to Boards of Pharmacy Staff
A more extensive Electronic
computer. Some state board
to-date information available
Licensure Transfer Program
offices already have the appro-
from all the boards,” says Moore.
(ELTP) training session for
priate hardware and will only
“We frequently find disciplinary
boards of pharmacy staff
receive the new software.
information in the database
members will be held late this
summer at the NABP headquarters in Park Ridge, Ill. This
“The upgrades will allow state
boards to use more features of
that an applicant has not
disclosed in the application.”
our system,” says Information
Besides showcasing the quick
Technology Manager Andrew
and effective methods to obtain
Duda, “and to use the current
that necessary information,
communications channels to
training has other pluses.
The training session will focus
contact our server and use the
“Training provides the opportu-
on features of the latest version
World Wide Web in the future.
nity to discuss what NABP can
of Lotus Notes board offices will
We will be processing data over
do for boards in very specific
use to communicate with NABP.
the Internet instead of through
terms,” says Moore. “Past
According to NABP President
dial-up connections.”
attendees said it was beneficial
year’s training is delayed
because more time is needed to
prepare the program training.
Jerry Moore, JD, RPh, “This
year’s training session will also
include the new Clearinghouse/
HIPDB program and some new
ELTP is a rapid and accurate
method for licensure transfer.
Within 24 to 48 hours from the
to gain an overview of NABP and
how the data they submit is
used to benefit the boards.”
time NABP recives a preliminary
The Licensure and Application
application, a Requests for
Database Programs department
Verification is e-mailed to the
will issue notices when train-
state boards, and their response
ing dates are finalized. Board
to NABP can be returned almost
staff members interested in
Along with the expanded
instantaneously. The program
attending will fill out a simple
training, NABP is providing
also verifies disciplinary infor-
registration form. Questions
hardware and software for the
mation, competency assessment
can be directed to Licensure
ELTP system to those board
scores, and Foreign Pharmacy
and Application Database
offices that require it. The
Graduate Equivalency Certifica-
Programs Director Glenn
hardware is a Pentium III 500
tion. “NABP’s disciplinary
Detweiler at 847/698-6227, or
MHz, or faster, personal
clearinghouse has the most up-
e-mailed to [email protected].
areas suggested by last year’s
participants. It is applicable to
both new and established board
staff members.”
NABP’s VIPPS Elected to ASAE “Honor Roll” (continued from page 87)
NABP’s VIPPS Web site, where
Associations Advance America
ation, citizenship, and commu-
they may access specific
Honor Roll is, indeed, an
nity service.
information that will assist
honor for NABP.”
them in choosing an online
pharmacy they can trust with
their family’s health care needs.
th
“Your program is a perfect
Now in its 10 year, the
example of how associations
Associations Advance America
play a vital role in helping the
awards program recognizes
nation adapt to complex and
“We are pleased that the ASAE
associations that propel
changing times,” says Michael
has recognized NABP and the
America forward with innova-
S. Olson, CAE, ASAE president
VIPPS certification program,”
tive projects in education,
and CEO, in regards to the
comments Jerry Moore, JD,
skills training, standards-
VIPPS program. “Contributions
RPh, NABP president. “To have
setting, business and social
such as yours are vital, and
been included on ASAE’s
innovation, knowledge cre-
add real value to society.”
92
NABP
NEWSLETTER
PDMA: Final Regulations (continued from page 89)
distributor must be kept under
proper conditions for storage,
Bulk Drugs/Pharmacy
Compounding
handling, and shipping, and
drugs, including those imported
for pharmacy compounding, the
importer of record is engaged in
written documentation show-
Under PDMA, the term “bulk
ing the proper conditions were
drugs” refers to Bulk Drug
maintained must be provided
Substances (BDS), which is
to the manufacturer or whole-
defined as drugs or drug
sale distributor with the
components, furnished in
returned drug products.
forms other than finished
wholesale distribution and must
be state licensed. Any agent
that subsequently distributes
the BDS must also be state
licensed.
Since the Agency does not
Controlled Room
Temperature/21 CFR
Part 205
regard starter packs as drug
The proposed regulations
Starter Packs
samples under the Act, use of
modified section 205.50(c) of
the term “starter” on drug
the wholesaler licensing
sample labeling is inappropri-
regulations to require, in the
ate and should not be used.
absence of labeled storage
Indigent Patient Programs
conditions on a prescription
The Agency has determined
to be stored according to the
that drug products distributed
definition of Controlled Room
to indigent patients programs
drug, that the drug would have
dosage form, that are intended
Temperature (CRT) as stated in
to furnish pharmacological
the revised edition of the US
activity or other direct effect in
Pharmacopeia (USP). The
the diagnosis, cure, mitigation,
Agency agreed that this proposal
treatment, or prevention of
is substantive rather than
disease, or to effect the struc-
technical since the definition of
ture or any function of the
CRT changed significantly from
body of humans. Because the
the edition of the USP in effect
statute makes all drugs subject
at the time of the original
to section 503(b)(1) of the Act
drafting of the proposed regula-
Samples in Retail
Pharmacies
subject to PDMA, a bulk drug
tions and the current USP
that is intended to furnish
edition. Therefore, this proposal
pharmacological activity or
has been withdrawn.
The proposal to consider the
other direct effect when it
Questions about the Prescrip-
presence of a drug sample in a
becomes a finished dosage form
tion Drug Marketing Act
retail pharmacy as a violation
that is a prescription drug is
(PDMA) and the final regula-
of the Act has been withdrawn.
subject to the PDMA. Require-
tions may be directed to:
However, the agency continues
ments concerning the whole-
Margaret O’Rourke, senior
to interpret the presence of
sale distribution of prescription
regulatory expert, Division of
samples in a retail pharmacy
drugs also apply to bulk drugs
Prescription Drug Compliance
as probative that samples are
because similar concerns exist,
and Surveillance (HFD-330),
being distributed in violation of
as with finished dosage form
Center for Drug Evaluation
the Act and would consider
products, involving personnel
and Research, US Food and
opening an investigation if
and facilities through which
Drug Administration. Phone:
prescription drug samples are
bulk drugs are distributed and
301/827-7296; e-mail:
found in a retail pharmacy.
how they are stored and
[email protected].
are not samples under the
PDMA when distributed
through manufacturer-sponsored indigent patient programs. Such programs
generally include appropriate
controls, documentation, and
verification of the distribution
and use of these products.
handled. For imported bulk
JUNE/JULY 2000
93
Survey Shows State Boards Gain Autonomy
More state boards of pharmacy
Permit and licensing fees bring
the 1997 Survey. The respond-
are working independently of
in the most revenue for the
ing state boards also showed
central agencies than in years
boards. Of the states that
gains in responsibility for
past, according to NABP’s
responded, five boards each
setting and collecting fees, at
biennial Resources and
awarded more than 15,000
69.5% and 67.4%, respectively.
Responsibilities Survey. In
registered pharmacist licenses.
1999, 47 boards of pharmacy
California granted the greatest
responded to the Survey,
number, with 29,423 licenses.
which covers such topics as
Alaska granted the fewest,
board organization, responsi-
awarding only 478 pharmacist
bilities, procedures, budget
licenses.
processes, and computer
Almost all of the boards have
made use of NABP’s Electronic
Licensure Transfer Program™
(ELTP™) computer system.
Only two states use a central
computer system in conjunc-
California, with its $5 million
tion with another state depart-
budget, reported the largest
ment, while 43 of the boards
Since the 1997 Survey, three
annual budget. Three states
make use of the ELTP computer
boards have begun functioning
have a budget of $2.5 million or
system. The ELTP system is
as autonomous agencies,
more, and 10 states have a
also used by the boards for
bringing the total members of
yearly budget of $1 million.
word processing (44%), finan-
capabilities.
boards that function independently of other state agencies to
27. Seventeen boards function
As the number of autonomous
boards has increased, so has
cial/budgeting (7%), and
database management (30%).
the state boards’ power to set
Copies of the 1999 Resources
budgets. Currently, 56.5% of
and Responsibilities Survey
the boards of pharmacy develop
may be obtained by contacting
budgets, while 30.4% report
the office of NABP’s executive
that a central agency controls
director/secretary at
Regardless of whether they
budget development. This is
847/698-6227.
function independently or not,
down from the 35% recorded in
as part of a central agency, and
the remaining three fall into
both categories, depending on
the task involved.
every state board of pharmacy
has the power to license and
discipline pharmacists. Nearly
all of the boards, 43, perform
pharmacy inspections. Only 27
boards are responsible for
Central Agency vs. Autonomous
Board Operations
enforcing the Federal Food,
6%
Drug, and Cosmetic Act, while
36%
31 have responsibility for the
Controlled Substances Act.
In terms of fines, only seven of
the boards do not impose
fines, which is down by two
58%
from the 1997 Survey. Of the
40 boards that can impose
fines, 12 boards did not collect
any fines, while New York and
New Jersey collected more
Central Agency
Both
Autonomous
than $200,000 each. The
average annual revenue from
fines was $36,410.
94
NABP
NEWSLETTER
Around theAssociation
Warren New Executive of
Colorado Board
New Board Members
Susan L. Warren, MS, JD,
Pharmacy announces two new
assumed the position of
members, Stan Haywood,
program administrator of the
RPh, and Wallace E. Nelson,
Colorado State Board of
RPh. Both Haywood and
Pharmacy effective April 10,
Nelson began their five-year
2000. She replaces Kent
terms in May.
on the
Governor’s
The North Carolina Board of
Council
on
Alcohol
and Other
Drug
Abuse and
the
Mount, who retired in March.
Haywood is
Institute on Alcohol and
Most recently, Ms Warren was
the owner
Other Drug Studies board of
manager of medical services
and chief
directors. Also involved in
delivery for the Colorado
pharmacist
education, Mr Nelson is the
Department of Labor and
of Prevo
chairman of the Perquimans
Employment and was respon-
Drugs in
County Board of Education.
sible for three medical service
Asheboro,
programs. She has also held
NC. A
graduate of
positions with the Colorado
Moné Serves on APhA
Board of Trustees
Department of Public Health
the University of North Caro-
Kentucky Board of Pharmacy
and Environment, the Colo-
lina School of Pharmacy, he
Executive Director Michael
rado Department of Regulatory
serves on the Mutual Drugs
Moné, JD, RPh, was elected
Agencies, and the Colorado
Legislative Affairs, and is a
to the American Pharmaceuti-
Attorney General’s Office.
member of the Asheboro City
cal Association (APhA) Board
Board of Education.
of Trustees as the 2000 –
public health from Harvard
Nelson is the director of
2001 speaker-elect for the
School of Public Health, a
Chowan Hospital Pharmacy in
house of delegates. Moné is
juris doctorate from the
Edenton, and is a graduate of
currently a member of NABP’s
University of Nebraska Law
the University of North Caro-
Multistate Pharmacy Juris-
School, and a degree from the
lina – Chapel Hill. He was
prudence Examination™
University of Nebraska.
chosen by the governor to serve
Review Committee.
Warren has a masters of
International VIPPS Program to be Launched (continued from page 83)
The new program will also offer
about that country’s specific
interest in participating in the
a separate interface to foreign
requirements, and about
VIPPS program. It is expected
Internet users from the exist-
online pharmacies certified in
the new VIPPS program will go
ing VIPPS pages, located at
that particular nation. Inter-
live on the Internet during the
http://vipps.nabp.net. Users
national VIPPS Web pages are
fourth quarter of this year. For
wishing to verify an interna-
currently under development
more information regarding
tional certified Web site will
by NABP.
VIPPS, please call NABP’s
click on the VIPPS “Click To
Verify” seal, and be instantly
linked to a series of VIPPS Web
site pages that list information
JUNE/JULY 2000
So far, licensing authorities
from Australia, Canada, and
New Zealand have expressed
Licensure Programs Department at 847/698-6227, or email via [email protected].
95
NABP Meeting Dates
Saturday-Sunday, July 29-30, 2000
Executive Committee Meeting,
NABP Headquarters, Park Ridge, Ill
Sunday-Tuesday, August 6-8, 2000
District III Meeting,
Grove Park Inn, Asheville, NC
Thursday-Saturday, August 10-12, 2000
District V Meeting,
Sheraton Hotel, Winnipeg, Manitoba, Canada
Thursday-Sunday, September 21-24, 2000
District VII & VIII Meeting,
Hilton Tucson East, Tucson, Ariz
Thursday-Sunday, October 5-8, 2000
District VI Meeting,
Arkansas Excelsior Hotel, Little Rock, Ark
Thursday-Saturday, October 19-21, 2000
District II Meeting,
Hilton Shorts Hotel, Short Hills, NJ
Friday-Sunday, November 10-12, 2000
District IV Meeting,
Radisson Hotel & Suites, Chicago, Ill
Saturday-Sunday, November 11-12, 2000
Executive Committee Meeting,
Beau Rivage Casino-Hotel,
Biloxi, Miss
Sunday-Tuesday,
November 12-14, 2000
Health Law Officers Conference,
Beau Rivage Casino-Hotel,
Biloxi, Miss
Thursday-Saturday, October 12-14, 2000
District I Meeting,
Sheraton Hotel, Burlington, Vt
ION OF BOA
AT
R
CI
DS
PHARM
OF
AC
Y
TIONAL ASS
O
NA
Sunday-Wednesday, October 15-18, 2000
Fourth International Conference of
Pharmaceutical Competencies,
Ottawa, Ontario, Canada
19 0 4
96
®
newsletter
National Association of Boards of Pharmacy
700 Busse Highway
Park Ridge, Illinois 60068
NABP
NEWSLETTER