State Board of
Pharmacy; 77 South High Street, Room 1702; Columbus, Ohio 43215-6126 Tel: 614/466-4143 Fax:
614/752-4836 Eml:
exec@bop.state.oh.us |
OHIO STATE BOARD OF PHARMACY NEWS ~~ FEBRUARY 2003 ~~ |
The Ohio State Board of Pharmacy News
is published by the Ohio State Board of Pharmacy and the National Association
of Boards of Pharmacy Foundation, Inc. to promote voluntary compliance of
pharmacy and drug law. The opinions
and views expressed in this publication do not necessarily reflect the
official views, opinions, or policies of the Foundation or the Board unless
expressly so stated. William T. Winsley,
MS, RPh - State News Editor Carmen A. Catizone,
MS, RPh - National News Editor & Executive Editor Courtney M. Karzen -
Editorial Manager |
State News Section |
Continuing Pharmacy Education Note The
Ohio State Board of Pharmacy's annual Jurisprudence Quiz is included as part
of this Newsletter. The questions
in the quiz relate to the topics covered in this Newsletter as well as
the May, August, and November 2002 issues.
If you need them, copies of the previous Newsletters can be
found on the Boards Web site at www.state.oh.us/pharmacy. Please
note that, due to the changes in the Continuing Pharmacy Education (CPE)
program outlined below, the deadline for submission of the completed quiz
has been changed to March 31, 2003.
Certificates will be mailed out beginning April 1, 2003, so any answer
sheets postmarked after March 31 will not be accepted for grading. |
Continuing Pharmacy Education Reminder On
February 1, 2002, the Board's rules on Continuing Pharmacy Education (CPE) changed.
It is still necessary for pharmacists to report six continuing education
units (CEUs) (60 hours) of CPE over a three-year reporting period, but the
only required subject is 0.3 CEUs (three hours) of Board-approved jurisprudence.
For those pharmacists whose license numbers begin with 03-3 and who report
this year, it will be necessary to show 5.7 CEUs (57 hours) of CPE in
any category (01, 02, 03, or 04) and 0.3 CEUs (three hours) in
Board-approved jurisprudence. Remember that, as an alternative to the 57
hours, a pharmacist may submit proof of certification in a Board-approved
pharmacy practice-specific specialty. In
addition to changing the reporting requirements, the Board is also in the
process of changing the time that CPE is reported by pharmacists. Due
to the fact that we now are required to have an outside vendor handle our
renewal forms and money instead of the State Treasurer's office, we are
separating the CPE reporting from the pocket identification card renewals.
Beginning in 2004 with those pharmacists whose license numbers begin with
03-1, pharmacists will be required to report their CPE during the
spring, prior to the time for renewal of the pocket identification card. We
are phasing in the earlier reporting time by making it voluntary for those
pharmacists who report this year (03-3). It will be mandatory in 2004
(03-1). Those pharmacists who have to report CPE this year will receive a CPE
report form along with a letter of explanation. If the CPE report form is
returned to the Board office prior to May 15, 2003, the pharmacist pocket
identification card renewal form will be sent without any CPE paperwork.
Since the outside vendor will charge us for any extra paper that they have to
handle, early reporting will help the Board save money. Our thanks go out to
those pharmacists who will meet the May 15, 2003 cutoff date. For those
pharmacists who will report in 2004 (03-1), you will be required to
report your CPE no later than May 15, 2004. For that reporting period,
you will be able to use certificates dated on or after March 1, 2001, that
were not used for the CPE reporting in 2001. Beginning in 2004, those who do
not return the CPE report form by the required date will not receive a
pharmacist renewal application until the CPE report form is received in the
Board office. |
What are Electronic Prescription Systems? Electronic
prescription transmission systems allow prescriptions to be sent
electronically from a prescriber to a pharmacy. The prescriber can send the
prescription directly from his or her computer to a pharmacy computer or
facsimile machine. Some of the systems are office-based, some are Web-based,
and some use a switching station to route the prescription to the pharmacy.
The office-based systems allow the prescriber to send a prescription
electronically directly from his or her office to the pharmacy. The Web-based
systems allow the prescriber to log onto a Web site, enter a prescription,
and the Web site then sends the prescription to the pharmacy. Systems
utilizing a switching station allow the prescriber to enter a prescription
that is transmitted to a switching station. The switching station identifies
the prescriber using specific data elements and then sends the prescription
to the pharmacy. Prior
approval by the Board of Pharmacy is required for all electronic prescription
transmission systems intended to be used in Ohio. The Board approval
process includes ensuring that each system has true "positive
identification" of the prescriber sending the prescription as defined in
Rule 4729-5-01 (N) of the Ohio Administrative Code (OAC), that every system
has security and accountability of all confidential information, that the
pharmacist receiving the prescription can identify that the system has approvable
status with the Board of Pharmacy, and that the pharmacist receiving the
prescription can verify that the prescription is legitimate. Some
important information to know about electronic prescription transmission
systems: |
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Ø |
No Schedule
II controlled substances may be sent to a pharmacy using an electronic
prescription transmission system. |
Ø |
There
can be multiple prescriptions, including controlled substances in Schedules
III, IV, and V, issued on one prescription blank when using an electronic
prescription transmission system to send a prescription to a pharmacy (see
OAC Rule 4729-5-13). |
Ø |
"Dispense
as Written" or "DAW" does not have to be handwritten on a prescription
sent through an electronic prescription transmission system (see Section
4729.38 of the Ohio Revised Code [ORC]). It does, however, require a positive
action by the prescriber to physically select "Dispense as Written"
or "DAW" when creating an electronic prescription. The electronic
prescription transmission system cannot automatically default to
"Dispense as Written" or "DAW." |
Ø |
You
may or may not see a signature on a prescription sent to a pharmacy by a
prescriber using an electronic prescription transmission system.
Computer-generated signatures are not recognized as a means of
"positive identification" and, therefore, are not required. If a
signature is present, the prescription must indicate that the signature was
computer-generated. |
Ø |
A
prescriber may elect to print a prescription from the electronic prescription
transmission system in his or her office and give it to the patient to
personally present it to a pharmacy. The prescription must be issued as per
any written prescription (see OAC Rules 4729-5-30 and 4729-5-13). These prescriptions
may contain a Schedule II controlled substance, there can only be one controlled
substance per prescription blank, "Dispense as Written" or
"DAW" must be handwritten, and the actual handwritten signature of
the prescriber must be on the prescription. |
The
systems that currently have obtained an approval status with the Board of
Pharmacy are: |
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Ø |
Allscripts |
Ø |
A4
Health Systems |
Ø |
E-Physician |
Ø |
Health
Probe |
Ø |
I-Scribe |
Ø |
Medical
Manager/WebMD |
Ø |
Pocket
Scripts |
Ø |
RxMadeSimple |
Disciplinary Actions Anyone
having a question regarding the license status of a particular practitioner,
nurse, pharmacist, pharmacy intern, or dangerous drug distributor in Ohio
should contact the appropriate licensing board. The Web sites listed below may include disciplinary actions for
their respective licensees. State Dental Board--614/466-2580, www.state.oh.us/den/ State Medical Board--614/466-3934, www.state.oh.us/med/ State Nursing Board--614/466-3947, www.state.oh.us/nur/ State Optometry Board--614/466-5115, www.state.oh.us/opt/ State Pharmacy Board--614/466-4143, www.state.oh.us/pharmacy/ State Veterinary Medical Board--614/644-5281, www.state.oh.us/ovmlb/ Drug Enforcement Administration--800/230-6844; www.deadiversion.usdoj.gov/ |
State Pharmacy Board: The
disciplinary actions listed below include only those where the individual's
license to practice has been suspended, revoked, or restricted, and does not
include any other actions taken by the Board. All actions may be seen in the minutes, which are posted on the
Board's Web site, then click on Board Minutes. Orders of the Board: Bruce Michael Linnemann,
RPh; Cincinnati - License revoked September 19, 2002. Settlement Agreements: Arch Joseph
Weber, RPh; Pickerington - License surrendered permanently November 4, 2002,
and may not be employed by or work in a facility licensed by the Board. Summary
Suspensions: [Sec. 3719.121 of the
Revised Code] Robert C. Hershbine, RPh;
North Royalton - Effective October 16, 2002. Lesley
Zimmerman Kennedy, RPh; Cincinnati - Effective November 4, 2002. Anthony
Kornokovich, RPh; Timberlake - Effective October 16, 2002. |
National News Section |
Applicability of the contents of articles in the
National Pharmacy Compliance News to a particular state or jurisdiction
should not be assumed and can only be ascertained by examining the law of
such state or jurisdiction. |
NABP Examination Security Group Detects FPGEE
Security Breach, Halts Examination The National Association of Boards of Pharmacy® (NABP®)
Examination Security Group recently discovered a security breach in the
Foreign Pharmacy Graduate Equivalency Examination® (FPGEE®) improperly caused
by a group of FPGEE candidates. As a result of the breach, administration of
the FPGEE has been halted as of November 19, 2002, until a new examination
can be established. The Association will notify candidates in writing
concerning future examination dates in early 2003. "Upon learning of this serious breach of security, NABP,
in keeping with its responsibility of aiding the state boards in the
protection of public safety and welfare, initiated a large-scale investigation
and will pursue all workable remedies to the fullest extent as permitted by
law," states NABP President John A. Fiacco. "We deeply regret
having to take such serious actions, but feel that it needs to be made clear
to candidates that NABP does not tolerate such security breaches. We are also
creating additional security measures to protect against possible future
breaches." Although all sources of the cause of the security
breach have not been determined, NABP is working to establish which scores
have been compromised by the breach. Accordingly, NABP has been forced to
take the following steps to protect the public health and welfare and ensure
the integrity of its testing program: |
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1. |
Computer-based FPGEE scores affected by the compromise will be
invalidated. |
2. |
Foreign Pharmacy Graduate Examination Committee. (FPGEC®)
certificates awarded to candidates who passed the exam affected by the
compromise will be invalidated. |
3. |
All existing FPGEE appointments have been cancelled and no new
appointments can be made at this time. |
This incident is isolated to the FPGEE and does not
affect NABP's North American Pharmacist Licensure Examination. (NAPLEX®),
Multistate Pharmacy Jurisprudence Examination. (MPJE®), or Disease State
Management (DSM) examinations. |
|
Candidates with questions may visit NABP's Web site at www.nabp.net
for updated information or e-mail the Customer Service Department at
custserv@nabp.net. Individuals without Internet access may contact NABP.s
Customer Service Department at 847/698-6227. |
FDA Approves Subutex, Suboxone to Treat Opiate
Dependence The US Food and Drug Administration (FDA) announced on
October 8, 2002, the approval of Subutex® and Suboxone® tablets for the treatment
of opiate dependence. Both medications treat opiate addiction by preventing
symptoms of withdrawal from heroin and other opiates. Based on the potential
for abuse of the drugs, FDA and the Department of Health and Human Services
recommended that Drug Enforcement Administration (DEA) place the active
ingredient, buprenorphine, in Schedule III under the Controlled Substances
Act (CSA). These products represent two new formulations of
buprenorphine and are supplied in 2 mg and 8 mg tablets that are placed under
the tongue and must be allowed to dissolve. The first of these formulations,
Subutex, contains only buprenorphine, and is intended for use at the
beginning of treatment for drug abuse. The other, Suboxone, contains both
buprenorphine and the opiate antagonist naloxone, and is intended to be the
formulation used in maintenance treatment of opiate addiction. Naloxone
guards against intravenous abuse of buprenorphine by individuals physically
dependent on opiates. Subutex and Suboxone are the first narcotic drugs
available for the treatment of opiate dependence that can be prescribed in
an office setting under the Drug Addiction Treatment Act (DATA) of 2000. Under this new law, medications
for the treatment of opiate dependence that are subject to less restrictive
controls than those of Schedule II can be prescribed in a doctor's office by
specially trained physicians. The sponsor, Reckitt Benckiser Pharmaceuticals, in
collaboration with FDA and with input from other Health and Human Services
agencies, has developed a comprehensive risk-management program designed to
deter abuse and diversion from its legitimate use in patients and physicians
regarding proper use of these drugs, close monitoring of drug distribution
channels, and child-resistant packaging. The risk-management program also provides for active
and passive surveillance to identify if and when the drugs are being abused.
The surveillance will include interviews with substance abusers, monitoring
local drug markets, data collection, and the monitoring of adverse event
reports. Reports of the results of these surveillance efforts will enable FDA
to identify untoward effects from the availability of buprenorphine and, if
indicated, to take appropriate actions to protect the public health. In addition, the provisions of the DATA include limits
on the number of patients individual physicians are allowed to treat and a
special DEA registration for the use of this drug, thus providing additional
safeguards as this drug enters the office-based treatment setting. |
USP Launches New Dietary Supplement Verification
Program The United States Pharmacopeia (USP) announced the
launch of its new Dietary Supplement Verification Program (DSVP) that will
help inform and guide pharmacists when recommending a dietary supplement. |
|
Currently, some dietary supplement products bear the
USP initials that are placed on a label voluntarily by a manufacturer. By
placing the USP initials on a dietary supplement products label, a manufacturer
states that they have complied with USP standards for one or all of the
following: strength and potency, dissolution and disintegration, and purity,
which are met by meeting a USP analytical monograph standard. DSVP is a program that manufacturers join voluntarily.
Unlike the USP initials, the DSVP mark represents that a participants
product was submitted for review and meets USP's rigorous criteria. Under
DSVP, USP evaluates and certifies dietary supplements according to stringent
standards for purity, accuracy of ingredient labeling, and proper and
sanitary manufacturing practices. The DSVP mark helps assure pharmacists
that the dietary supplements they recommend: |
|
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Contain the ingredients stated on the label; |
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Have the declared amount of strength of ingredients; |
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Will dissolve effectively to release the contents of the
dietary supplement for absorption into the body; |
Ø |
Was tested for harmful contaminants such as heavy metals, E.
coli, and pesticides; and |
Ø |
Have been manufactured using safe, sanitary, and
well-controlled procedures. |
Once a product has been certified, USP will
periodically conduct random off-the-shelf tests on verified products to
ensure they continue to meet DSVP's strict standards. USP also will continue
to conduct audits of manufacturer sites for compliance with DSVP
requirements. Dietary supplement products bearing the DSVP mark began
to appear on retailer and pharmacy shelves in December 2002. Currently,
several companies have joined DSVP: Pharmavites Nature Made, Weider Nutrition
International Inc's Schiff brand of Move Free joint care products, and Inverness
Medical Innovations. For a list of DSVP-certified products or for further
information about DSVP, visit www.usp-dsvp.org. |
Accutane Medication Guide Changes The updated version of the Accutane Medication Guide
(MedGuide), distributed to pharmacists in early September 2002, is now
printed on tan paper and replaces all other versions of the MedGuide.
Pharmacists should discard all MedGuides printed on white, yellow, or
green paper, and distribute only those printed on the tan paper. This
Medication Guide for Accutane summarizes, in simple language, the
professional package insert, including the approved indication for Accutane
and major adverse events reported in the package insert. The revision to the
MedGuide was developed in conjunction with the US Food and Drug Administration
(FDA), and replaces the MedGuide released in July 2002. |
Misidentification of Alphanumeric Characters This column was prepared by the Institute for Safe Medication
Practices (ISMP). ISMP is an independent nonprofit agency that works closely
with US Pharmacopeia (USP) and the Food and Drug Administration (FDA) in
analyzing medication errors, near misses, and potentially hazardous conditions
as reported by pharmacists and other practitioners. ISMP then makes
appropriate contacts with companies and regulators, gathers expert opinion
about prevention measures, then publishes its recommendations. If you would
like to report a problem confidentially to these organizations, go to the
ISMP Web site (www.ismp.org) for links with USP, ISMP, and FDA. Or
call 1-800/23-ERROR to report directly to the USP-ISMP Medication Errors
Reporting Program. ISMP address: 1800 Byberry Rd, Huntingdon Valley, PA
19006. Phone: 215/947-7797. E-mail: ismpinfo@ismp.org. A potentially serious medication error was reported
recently because a lower case "L" was the end letter in a drug name
and was misread as the number 1. An order for 300 mg of TEGRETOL
(carbamazepine) BID was misinterpreted as 1300 mg BID. The letter
"L" at the end of Tegretol had been written very close to the
numerical dose of 300 mg on a prescription for the patient (Tegretol300 mg).
The pharmacist was unfamiliar with the medication and the pharmacy computer
system did not alert him that the dose exceeded safe limits. The patient
received only one dose in error before another pharmacist caught the mistake
and the patient was informed. The single dose made the patient lethargic, but
not seriously toxic. It is not uncommon to read a letter or number
differently than the writer intended. Recently, a pharmacist read the word
"IODINE" in a space on a patient profile for allergy alerts. Yet, a
second pharmacist read the allergy as "LODINE". Computerized physician order entry (CPOE) can overcome
most problems with poor handwriting and, fortunately, use of such technology
is growing. However, even typed or computerized physician orders may not help
prevent all problems. Anyone familiar with e-mail knows how easy it is to misidentify
a computer-generated lower case letter L (l) in an e-mail address as the
numeral one (1), or the letter O as a zero (0)! Even when using character
recognition software, drug names may be translated incorrectly. For example,
when we tested Lodine, typed with a lower case L, the software recognized the
drug name as Iodine. Likewise, it's easy to confuse the upper case letter Z
with the number 2. In fact, research conducted by Bell Laboratories found
that some symbols are more vulnerable than others to misidentification (Nierenberg
GI. Do it right the first time. New York: John Wiley and Sons 1996). The
previously mentioned characters (I/1; O/0 and Z/2) plus the number 1, which
can look like a 7, accounted for over 50% of the errors caused by character
misidentification in the study. Adequate spacing between the drug name and the dose is
crucial on prescriptions and electronic formats such as pharmacy computer
selection screens, computer-generated medication labels and records, printed
forms and communications, shelf labels, etc. For example, even a clearly
typed order for 25 mcg of LEVOXYL (levothyroxine) could be misread as
125 mcg if it appears without proper spacing as Levoxyl25 mcg, especially
since both strengths are available. Many drug name recognition errors can be reduced with
block printing using upper case characters. Weve seen some prescription
forms incorporate shaded blocks for this purpose. Pharmacists should
encourage this style of writing and use of such forms. Symbolic differentiation
is another way to distinctively convey a symbol's meaning. Throughout
Europe, it's common to see a zero written with a slash through it to
differentiate it from the letter "O." The number 7 can be written
with a bar through it to prevent confusion with the number 1. The letter
"Z" with a bar through it also can prevent confusion with the
number 2. Stricter adherence to these principles would help reduce character
misidentification. The potential for name-related errors is greatly reduced when
pharmaceutical manufacturers incorporate practitioner testing of drug names
and doses into their new drug development process. By using samples of
cursive and printed characters practitioners can often recognize potential
problems, which can help manufacturers avoid dangerous product names.
Finally, the drug and dose have to make sense to the pharmacist; otherwise
follow up with the prescriber is necessary. However, the context in which
the order is being read may not always be helpful in properly identifying
alphanumeric characters. While it would be unlikely to read ZETAR as
"2TAR," it would be easy to read an order for "HCTZ50mg"
as either hydrocortisone 250 mg or hydrochlorothiazide 50 mg (and yes, this
has actually happened!). Avoiding drug name abbreviations is a subject we
will tackle in the future. |
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2003 JURISPRUDENCE QUIZ |
ANSWER SHEET FOLLOWS |
(covering
May 2002, August 2002, November 2002, and February 2003 issues of the State
Board Newsletter)
1. As of
February 1, 2002, the rule for continuing education was changed. According to the new requirements, which
of the following are true? A. A pharmacist is required to
submit 60 hours of continuing education every three years. B. Three hours must be in Board
approved jurisprudence C. Fifty-seven hours may be in any
category D. All of the above 2. Starting
in 2004, continuing education must be submitted by May 1. The hours submitted at this time may be
from March 1, 2001, if they were not used for the prior reporting period in
2001. A. True
B. False 3. According
to the Dietary Supplement Verification Program (DSVP), announced by the US
Pharmacopeia, which of the following criteria will be evaluated? A. Evaluation of manufacturers'
quality systems by means of an audit B. Quality control and
manufacturing data review C. Laboratory evaluation of product
samples and regular monitoring D. All of the above 4. Under the
new federal law addressing Office-based Treatment of Narcotic Addiction,
qualified physicians will be able to prescribe or dispense certain schedule
III, IV, or V narcotic drugs for opiate addiction treatment. A. True B. False 5. Which of
the following are true regarding office-based treatment of narcotic addition? A. A physician must obtain a waiver
from SAMHSA to prescribe/dispense to opiate-addicted patients B. A physician may treat up to 50
patients at any one time C. A schedule III, IV or V opiate
must have FDA approval for use in narcotic addiction treatment D. A and C only 6. According
to an April 10, 2002 Talk Paper, the FDA issued warning letters to three
pharmacies to cease sales of nicotine lollipops and lip balm for which of the
following reasons? A. The products are being
compounded and sold without a physician's prescription B. They contain a form of nicotine
that is not used in FDA-approved smoking cessation products C. The products sold over the
Internet present a risk of accidental use by children because of their
candy-like appearance D. All of the above 7. Methotrexate
is used in low doses for which of the following conditions? A. Rheumatoid arthritis B. Psoriasis C. Asthma D. All of the above 8. Lotronex
has been reintroduced with restricted conditions of use. A. True B. False |
9. Which of
the following are true regarding Xyrem? A. Xyrem is the trade name for
gamma hydroxybutyrate B. Xyrem will be distributed
nationally from one central pharmacy C. Xyrem is a schedule III drug D. All of the above 10. Synthroid has
received FDA approval for which of the following conditions? A. Thyroid disease management as
replacement or supplemental therapy for hypothyroidism B. Pituitary thyroid-stimulating
hormone suppression C. All of the above D. None of the above 11. The dated
yellow Accutane Qualification Sticker indicates which of the following to
the dispensing pharmacist? A. The female patient has had two
negative pregnancy tests prior to beginning therapy B. The patient has signed an
informed consent about the risks of potential birth defects C. The patient is to use two forms
of birth control while taking Accutane D. All of the above 12. Distribution of
Potassium Iodide for use in the event of a radiation accident is taking place
in which of the following Ohio locations? A. Lake, Geauga, and Ashtabula counties (Perry Nuclear Power Plant) B. Ottawa and Lucas counties
(Davis-Besse Nuclear Power Plant) C. Columbiana county and the city
of East Liverpool (Beaver Valley Nuclear Power Plant in Pennsylvania) D. All of the above 13. There is a new
national poison control number available.
Which number is correct? A. 1-800/222-2122 C. 1-866/222-2122 B. 1-800/222-1222 D. 1-866/222-1222 14. Because of the
number of fatalities from errors with oral methotrexate, physicians and
pharmacists should consider it a high alert medication and take measures to
help reduce the risk of an error. A. True B. False 15. Electronic
prescription transmission systems can send prescriptions directly from a
prescriber's computer to the pharmacy's fax or computer. These Board approved systems are which of
the following? A. Office-based B. Web-based C. Switching stations to transmit
the electronic prescription D. All of the above 16. Which of the
following are true about Board-approved electronic prescription transmission
systems? A. No schedule II controlled
substance prescriptions may be sent using these systems B. The prescriber's signature is
not required C. Transmission of several
prescriptions per page may legally contain controlled substances D. All of the above [End of Quiz] |
-
ANSWER SHEET -
State Board
Newsletter February 2003 Jurisprudence Quiz
JURISPRUDENCE REQUIREMENT FOR CPE To receive a certificate of credit, please complete this
form and mail it to the address below with a check for $4.00 payable to Adherence,
Inc. A certificate will be mailed
after April 1, 2003 to those receiving a passing score of 75 or
better. |
PLEASE FILL IN YOUR ANSWER
TO EACH QUESTION
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A |
B |
C |
D |
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A |
B |
C |
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1. |
O |
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O |
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9. |
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O |
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O |
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10. |
O |
O |
O |
O |
3. |
O |
O |
O |
O |
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11. |
O |
O |
O |
O |
4. |
O |
O |
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12. |
O |
O |
O |
O |
5. |
O |
O |
O |
O |
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13. |
O |
O |
O |
O |
6. |
O |
O |
O |
O |
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14. |
O |
O |
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7. |
O |
O |
O |
O |
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15. |
O |
O |
O |
O |
8. |
O |
O |
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16. |
O |
O |
O |
O |
JURISPRUDENCE CPE; ADHERENCE, INC.; P. O. BOX 42407; CINCINNATI, OH
45242-0407 (513/794-1642)
No
CPE credit can be granted for Answer Sheets postmarked after March 31, 2003. |
NAME: [Please Print Or Type] |
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