NOTE: The following Minutes are provided for
informational purposes only. If you would like to obtain an official copy of
these Minutes, please contact the State
Board of Pharmacy at 614/466-4143 for instructions and fee. |
Ohio State Board of Pharmacy
October 1, 2, 3, 2001
MONDAY, OCTOBER 1, 2001
8:00 a.m. ROLL CALL
The State Board of Pharmacy convened in Room 1919, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio with the following members present:
Ann D. Abele, R.Ph. (President); Gregory Braylock, R.Ph.; Suzanne R. Eastman, R.Ph.; Robert P. Giacalone, R.Ph.; Lawrence J. Kost, R.Ph.; Nathan S. Lipsyc, R.Ph.; Dorothy S. Teater, Public Member; and James E. Turner, R.Ph.
Also present were William T. Winsley, Executive Director; Timothy Benedict, Assistant Executive Director; William McMillen, Licensing Administrator; Mark Keeley, Legislative Affairs Administrator; David Rowland, Legal Affairs Administrator; Robert Cole, Compliance Supervisor; and Sally Ann Steuk, Assistant Attorney General.
8:05 a.m.
RES. 2002-03 After discussion, Mr. Turner moved that the Board issue the following recognition resolution regarding the retirement of Compliance Agent David Avery after 15 years of service. The motion was seconded by Mr. Lipsyc and approved by the Board (Aye-7/Nay-0).
RESOLUTION OF THE BOARD
WHEREAS, the investigative efforts over the last fifteen years of David D. Avery, a Compliance Agent with the Ohio State Board of Pharmacy, directly led to the arrest and conviction of over 400 individuals who diverted and/or abused pharmaceutical drugs; and
WHEREAS, David D. Avery
demonstrated professionalism in carrying out the responsibilities of his
position with the Board; and
WHEREAS, David D. Avery
put forth extraordinary effort and dedication to duty during his fifteen years
with the Board; therefore
BE IT RESOLVED that we,
the undersigned Members of the Ohio State Board of Pharmacy, in its one hundred
and seventeenth year, do hereby express our profound appreciation to Board
Compliance Agent David D. Avery for his dedication and service to the Board and
the citizens of Ohio, and
BE IT FURTHER RESOLVED,
that this resolution be spread upon the permanent minutes of the Ohio State
Board of Pharmacy and a copy presented to:
DAVID D. AVERY
RES. 2002-036 Mr. Winsley then discussed the invitation he had received to address the Board of Directors of the Pharmaceutical Care Management Association (PCMA) at their meeting in Las Vegas, Nevada. After discussion, Mr. Turner moved that Mr. Winsley be authorized to attend this meeting, that his expenses be paid by the Board, and that the time spent be considered as time worked. The motion was seconded by Mrs. Teater and approved by the Board (Aye-7/Nay-0).
8:10 a.m.
Mr. Kost moved that the Board go into Executive Session for the purpose of the investigation of complaints regarding licensees and registrants pursuant to Section 121.22(G)(1) of the Revised Code and for the purpose of conferring with an attorney for the Board regarding pending or imminent court action pursuant to Section 121.22(G)(3) of the Revised Code. The motion was seconded by Ms. Eastman and a roll call vote was conducted by President Abele as follows: Braylock-Yes, Eastman-Yes, Giacalone-Yes, Lipsyc-Yes, Kost-Yes, Teater-Yes, and Turner-Yes.
10:50 a.m.
RES. 2002-037 The Executive Session ended and the meeting was opened to the public. Mr. Lipsyc moved that the Board accept the settlement offer in the matter of Fay Christine Grant-Young subject to the additional stipulations added by the Board. The motion was seconded by Mr. Kost and approved by the Board (Aye-7/Nay-0). The settlement agreement will become final upon the signature of all parties.
RES. 2002-038 Mr. Turner then moved that the Board accept the settlement offer in the matter of Trumbull Township Volunteer Fire Department under the terms offered. The motion was seconded by Mr. Giacalone and approved by the Board (Aye-7/Nay-0). The settlement agreement will become final upon the signature of all parties.
RES. 2002-039 Ms. Eastman moved that the Board deny the settlement offer submitted in the matter of Dennis Farina and that the hearing be held as scheduled. The motion was seconded by Mrs. Teater and approved by the Board (Aye-7/Nay-0).
RES. 2002-040 Mr. Winsley announced that the following agreement in the matter of Jeffrey Garbe had been signed by all parties and was now effective:
SETTLEMENT
AGREEMENT WITH THE STATE BOARD OF PHARMACY
(Docket No. D-010615-074)
In The Matter Of:
JEFFREY J. GARBE, R.Ph.
5280 Mahogany Ridge Drive
Naples, Florida 34119
(R.Ph. No. 03-1-17551)
This Settlement Agreement is entered into by and between Jeffrey J. Garbe, R.Ph. and the Ohio State Board of Pharmacy, a state agency charged with enforcing the Pharmacy Practice Act and Dangerous Drug Distribution Act, Chapter 4729. of the Ohio Revised Code.
Jeffrey J. Garbe enters into this Agreement being fully informed of his rights afforded under Chapter 119. of the Ohio Revised Code, including the right to representation by counsel and the right to a formal adjudication hearing on the issues contained herein.
Jeffrey J. Garbe is knowingly and voluntarily acknowledging that, in order to settle the disciplinary charges that have been filed by the Board against him and in order to obviate the need to conduct an administrative hearing to consider possible disciplinary sanctions against Jeffrey J. Garbe’s license to practice pharmacy in the State of Ohio, Jeffrey J. Garbe enters into this Agreement on the basis of the following stipulations, admissions, and understandings:
(1) The Ohio State Board of Pharmacy is empowered by Section 4729.16 of the Ohio Revised Code to suspend, revoke, place on probation, refuse to grant or renew an identification card, or impose a monetary penalty on the license holder for violation of any of the enumerated grounds.
(2) On or about June 15, 2001, pursuant to Chapter 119. of the Ohio Revised Code, Jeffrey J. Garbe was notified of the allegations or charges against him, his right to a hearing, his rights in such hearing, and his right to submit contentions in writing. Further, a hearing was requested and scheduled for December 4, 2001.
(3) Records of the Board of Pharmacy indicate that Jeffrey J. Garbe was originally licensed in the State of Ohio on October 31, 1988, pursuant to examination, and is currently licensed to practice pharmacy in the State of Ohio.
(4) Jeffrey J. Garbe is addicted to the use of controlled substances, to wit: he has admitted to the Florida Board of Pharmacy, and to a Compliance Specialist with the Ohio State Board of Pharmacy, that he is addicted to controlled substances. He stated that he was using approximately twenty tablets of Lorcet and six tablets of Xanax per day for about one and one-half years. Such conduct indicates that Jeffrey J. Garbe falls within the ambit of Sections 3719.121(A), and 4729.16(A)(3) of the Ohio Revised Code.
(5) On January 6, 2000, the Florida Board of Pharmacy issued its Final Order in Department of Health vs. Jeffrey J. Garbe, R.Ph., Case No. 97-18156. On September 17, 1998, Jeffrey J. Garbe has been charged in an Administrative Complaint with diverting drugs, including Percodan, from his employer, Publix Pharmacy, from 1996 through September, 1997.
Wherefore, in consideration of the foregoing and mutual promises hereinafter set forth, and in lieu of a formal hearing at this time, Jeffrey J. Garbe knowingly and voluntarily agrees with the State Board of Pharmacy to the following:
(1) Jeffrey J. Garbe must abide by the conditions as set forth in the Final Order of the Florida Board of Pharmacy dated January 6, 2000.
(2) Until such time as the Florida Board of Pharmacy removes all conditions from Jeffrey J. Garbe’s license to practice pharmacy, Jeffrey J. Garbe’s license to practice pharmacy in the State of Ohio will be placed on probation; during which time Jeffrey J. Garbe shall not serve as a Responsible Pharmacist or serve as a pharmacy preceptor in Ohio.
(3) Jeffrey J. Garbe must inform the Ohio State Board of Pharmacy if he plans to return to Ohio during his probationary period in Florida to practice pharmacy in Ohio: whereupon, an administrative hearing will be held to determine Jeffrey J. Garbe’s compliance with his Florida sanctioned recovery and his fitness to continue his practice of pharmacy.
If, in the judgment of the Board, Jeffrey J. Garbe appears to have violated or breached any terms or conditions of this Agreement, the Ohio State Board of Pharmacy reserves the right to, at any time, revoke probation, modify the conditions of probation, and reduce or extend the period of probation, and/or the Board may institute formal disciplinary proceedings for any and all possible violations or breaches, including but not limited to, alleged violation of the laws of Ohio occurring before the effective date of this Agreement.
Jeffrey J. Garbe acknowledges that he has had an opportunity to ask questions concerning the terms of this agreement and that all questions asked have been answered in a satisfactory manner. Any action initiated by the Board based on alleged violation of this Agreement shall comply with the Administrative Procedure Act, Chapter 119. of the Ohio Revised Code.
Jeffrey J. Garbe waives any and all claims or causes of action he may have against the State of Ohio or the Board, and members, officers, employees, and/or agents of either, arising out of matters which are the subject of this Agreement. Jeffrey J. Garbe waives any rights of appeal pursuant to Chapter 119. of the Ohio Revised Code. This Settlement Agreement shall be considered a public record, as that term is used in Section 149.43 of the Ohio Revised Code, and shall become effective upon the date of the Board President’s signature below.
/s/ Jeffrey Garbe, R.Ph. |
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/d/ 9-8-01 |
Pharmacist Name, Respondent |
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Date of Signature |
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/s/ N/A |
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Name, Attorney for
Respondent |
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Date of Signature |
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/s/ Ann D. Abele |
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/d/ 10/1/2001 |
Ann D. Abele, President,
Ohio State Board of Pharmacy |
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Date of Signature |
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/s/ Sally Ann Steuk |
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/d/ 10-1-01 |
Sally Ann Steuk, Ohio Assistant Attorney
General |
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Date of Signature |
RES. 2002-041 The Board members then renewed the discussion on the proposed changes to the Administrative Code Rules that had been suggested by the Ad Hoc Committee on Rule Review. After significant discussion, Mr. Giacalone moved that Rule 4729-7-02 be filed as amended by the Board. The motion was seconded by Ms. Eastman and approved by the Board (Aye-4/Nay-3). Mr. Giacalone then moved that the following rules be approved for filing prior to the Public Hearing scheduled for November 5, 2001. The motion was seconded by Mr. Braylock and approved by the Board (Aye-7/Nay-0).
4729-1-01 Public
notice of hearing to consider proposed rule changes.
(A) Reasonable
public notice, as required by section 119.03 of the Revised Code, shall be given
at least thirty days prior to the date set for the public hearing as
follows:
(1) By
placing such notice in the register of Ohio or by advertising
such notice, one time, in at least one newspaper of general circulation in the
state of Ohio at least thirty days prior to the date set for the public
hearing.
(2) By
mailing, e-mailing, or faxing such notice, one time, to all subscribers
on the board's sunshine notice mailing list at least thirty days prior to
the date set for the public hearing.
(3) By
mailing, e-mailing, or faxing such notice, one time, to all
persons who have requested the board to provide notification of any proposed
rule changes at least thirty days prior to the date set for the public
hearing.
(4) By
placing such notice on the board's world wide web home page at least thirty
days prior to the date set for the public hearing, and remaining there
until the public hearing record is closed.
(B) The board shall furnish the full text of the
proposed rules as follows:
(1) By mailing to any person who requests such in
writing and who pays the cost of copying and mailing.
(2) By e-mailing to any person upon request.
(3) By
posting on the board's world wide web home page and remaining there until the
public hearing record is closed.
4729-1-02 Notice
of meetings.
Any person may determine
the time and place of all regularly scheduled meetings and the time, place, and
purpose of all special meetings of the state board of pharmacy, as required by
division (F) of section 121.22 of the Revised Code, by:
(A) Written
request to the state board of pharmacy.
(1) Written
requests shall include the name, mailing address, and telephone number of the
person making the request.
(2) Written
requests shall be accompanied by a service fee of twenty-five dollars which
shall be valid for the fiscal year of July first through June thirtieth.
(3) Notice
for the annual renewal of this request will be sent by the board of pharmacy by
June first of each year and shall be due no later than July thirty-first of
each year.
(B) Calling
the telephone number of the state board of pharmacy between the normal business
hours of eight a.m. to four-thirty p.m., Monday through Friday, legal holidays
excepted.
(C) Consulting
the official record of all board of pharmacy regularly scheduled and special
meetings located at office of the state board of pharmacy.
(D) Viewing
the state board of pharmacy's world wide web home page.
4729-3-01 Definitions.
As
used in Chapter 4729-3 of the Administrative Code:
(A) "Pharmacy
internship" means the supervised practical experience required for
licensure as a registered pharmacist.
The purpose of the pharmacy internship program is to provide those
individuals, who intend to become registered pharmacists, with the knowledge and
practical experience necessary for functioning competently and effectively
upon licensure.
(B) "Supervised
practical experience" is the experience obtained at an internship site and
which is conducted in accordance with the "National Association of Boards of
Pharmacy - American Association of Colleges of Pharmacy" publication
"The Internship Experience," or a similar outline and/or manual
approved by the board of pharmacy.
(C) "Internship
site" means a pharmacy licensed as a terminal distributor of dangerous
drugs pursuant to Chapter 4729. of the Revised Code, except as provided in
paragraph (C) or (D) of rule 4729-3-05 of the Administrative Code, and whose
license is in good standing.
(D) "Preceptor"
is the individual responsible for seeing that the intern is properly supervised
and exposed to all aspects of the internship program defined as the supervised
practical experience.
(1) A
"preceptor" is a pharmacist who holds a current identification card
which is in good standing; or, is a person who is of good moral character and
is qualified to direct the approved experience in the area approved by the
director of internship pursuant to rule 4729-3-05 of the Administrative Code.
(2) A
person may serve as the preceptor for more than one intern. The number of interns engaged in the
practice of pharmacy at any time is limited to not more than two for each
pharmacist on duty.
(3) A
preceptor must report to the board on the progress and aptitude of an intern
when requested by the director of internship.
(E) "Director
of internship" has the same meaning as provided in section 4729.11 of the
Revised Code.
(F) "In
good standing" means that the licensee or registrant has not been denied
the privilege of supervising interns by the board.
(G) "Statement
of Preceptor" is the form which must be received by the board of pharmacy
for each pharmacy intern within thirty days of beginning internship under a
preceptor's supervision.
(1) No
credit will be given for practical experience obtained prior to thirty days of
the date that the "Statement of Preceptor" form is received by the
board office; except, that in the event of extraordinary circumstances and when
due to no fault of the intern, the board may accept a retroactive date of
filing for the "Statement of Preceptor."
(2) The
intern must file a "Statement of Preceptor" form whenever he/she
changes internship sites and/or preceptors.
(H) "Practical
experience affidavit" is the form which must be used to submit practical
experience for internship credit.
(1) Practical
experience must be itemized to the nearest half hour on the affidavit by the
total number of hours obtained each week.
The hours reported must be able to be documented by payroll or other records
which may be examined by the board of pharmacy upon reasonable notice.
(2) Practical
experience affidavits must be signed by the preceptor on file with the board of
pharmacy. In the event of the unavailability
of the preceptor's signature due to extraordinary circumstances and due to no
fault of the intern, the board may accept an alternative method for
verification of a practical experience affidavit.
(3) Practical
experience affidavits for a calendar year may be filed at any time, except that
they must be received in the board office or postmarked no later than the first
day of March of the following year.
(I) "School
of pharmacy" has the same meaning as a college of pharmacy or a department
of pharmacy of a university, which has been recognized and approved by the
state board of pharmacy.
4729-3-02 Registration
as a pharmacy intern.
(A) A
certificate of registration as a pharmacy intern shall only be issued for the
purpose of allowing those individuals who intend to become registered
pharmacists the opportunity to obtain the practical experience required for
examination and registration as a pharmacist.
(B) If a person desires to work as a pharmacy intern
in Ohio, he/she must:
(1) Have
successfully completed forty-eight semester or seventy-two quarter hours of college
and have been accepted into a school or college of pharmacy or a
department of pharmacy of a university recognized and approved by the state
board of pharmacy; or
(2) Have
obtained a first professional degree in pharmacy from a program which has been
recognized and approved by the state board of pharmacy; or
(3) Have
established educational equivalency by obtaining a Foreign Pharmacy Graduate
Examination Commission (FPGEC) certificate, and have established proficiency
in spoken English by successfully completing the Test of Spoken English (TSE)
or its equivalent;
(4) Apply
to the state board of pharmacy for registration as a pharmacy intern.
4729-3-03 Application
for registration as a pharmacy intern.
(A) Every
person desiring to register as a pharmacy intern shall submit the following to
the state board of pharmacy:
(1) A
completed application form as provided by the board;
(2) A
three- by four-inch head and shoulders photograph taken within the previous six
months;
(3) Fee;
(4) A
transcript certifying that the applicant has in fact successfully completed a
minimum of forty-eight semester or seventy-two quarter hours of college work;
and
(5) A certificate of acceptance into a school or
college of pharmacy or a department of pharmacy of a university
recognized and approved by the state board of pharmacy.
or
(6) All
items listed in paragraphs (A)(1) to (A)(3) of this rule and certification of
having obtained a first professional degree in pharmacy from a program which
has been recognized and approved by the state board of pharmacy; or
certification of having established educational equivalency by obtaining a
“Foreign Pharmacy Graduate Examination Commission (FPGEC)” certificate, and
evidence of successful completion of the “Test of Spoken English (TSE)” or its
equivalent.
(B) The
state board of pharmacy may register an applicant as a pharmacy intern as soon
as the state board of pharmacy receives all the required items set forth in
paragraphs (A)(1) to (A)(5) or paragraph (A)(6) of this rule.
(C) The
state board of pharmacy may, pursuant to rule 4729-5-04 of the Administrative
Code, deny the issuance of a certificate of registration or an identification
card to practice as a pharmacy intern.
4729-3-04 Pharmacy
intern identification card renewal.
A pharmacy intern may renew his/her
identification card each year provided he/she is actively working toward the
requirements for licensure as a pharmacist and otherwise meets the
requirements and rules of the state board of pharmacy. The state board of pharmacy may, pursuant to
rule 4729-5-04 of the Administrative Code, deny the issuance of an
identification card to practice pharmacy as an intern.
(A) An
intern shall be considered to be actively working towards licensure as a
pharmacist if he/she has complied with all of the statutes and rules regarding
internship since registration as a pharmacy intern, and:
(1) He/she
is enrolled in a college school of pharmacy or is able to provide
evidence that he/she has been, or will be, accepted for enrollment or
re-enrollment in a college school of pharmacy; or
(2) He/she
is a member of the armed forces and can provide evidence that he/she has been,
or will be, accepted for enrollment or re-enrollment in a college
school of pharmacy upon his/her release from the armed forces; or
(3) He/she
is able to provide evidence of obtaining a first professional degree in
pharmacy from a school or college of pharmacy or a department of pharmacy
of a university recognized and approved by the state board of pharmacy; or
(4) He/she
is able to provide evidence of obtaining a “Foreign Pharmacy Graduate
Examination Commission (FPGEC)” certificate, and can provide evidence of
successful completion of the “Test of Spoken English (TSE)” or its equivalent.
(B) An intern who has
obtained a first professional degree in pharmacy from a school or college
of pharmacy or a department of pharmacy of a university recognized and
approved by the state board of pharmacy, or who has established
equivalency by obtaining a “Foreign Pharmacy Graduate Examination Commission
(FPGEC)” certificate, may renew his/her license only once. In the event of extraordinary circumstances
and when due to no fault of the intern, the board may approve additional
renewals.
4729-3-05 Internship
credit.
(A) No
internship credit shall be granted by the board for practical experience
obtained before registration as an intern or during a period when the intern's
registration has lapsed.
(B) Internship
credit may be granted for practical experience obtained when the intern is
registered and attending classes in the academic program of a school of
pharmacy, other than the structured academic program as provided for in paragraph
(C) of this rule.
(C) Internship credit may
be gained for practical experience obtained in a structured program for which
academic credit is awarded (e.g., externship, clerkship). Such credit shall be limited to the number
of hours for which the structured program has been approved by the state board
of pharmacy. Internship credit shall
be granted only when the intern obtains a passing grade for the course
involved. A school or college of
pharmacy which desires to conduct such structured programs eligible for
approval shall make a written request on forms provided by the board.
(D) Up
to five hundred hours of internship credit may be obtained at a site other than
a pharmacy licensed as a terminal distributor of dangerous drugs (e.g.,
manufacturing, research, consulting, drug information, and drug utilization
review). To receive credit for such
experience, a formal request must be submitted to the director of internship
for approval prior to beginning the experience in these areas. The request shall include a detailed
description of the contemplated internship with respect to time, place, duties,
responsibilities, professional supervision, and the person supervising the
experience.
(E) Internship
credit may be denied for the practical experience accumulated when an intern
is found to be guilty of violation(s) pursuant to section 4729.16 of the
Revised Code.
(F) The
pharmacy internship requirement for the licensure examination shall be deemed
satisfactorily completed when the intern has filed affidavits certifying that
he/she has obtained a total of one thousand five hundred hours of supervised
practical experience and such affidavits have been accepted by the board of
pharmacy.
4729-5-07 Recognized
and approved colleges schools of pharmacy.
(A) To be recognized and
approved by the state board of pharmacy, a school or college of pharmacy
or a department of pharmacy of a university shall meet the requirements
as set forth by the board. The board
may utilize the reports, requirements, and recommendations of any recognized
accrediting organization or higher education governing board in determining the
requirements. The board of pharmacy
shall take into consideration, but not be bound by, accreditation standards
established by the "American Council on Pharmaceutical Education".
(B) For
the purpose of satisfying the requirements of division (C) of section 4729.08
of the Revised Code, graduates of a school or college of pharmacy or
a department of pharmacy of a university located outside the United States
shall establish educational equivalency by obtaining a "Foreign Pharmacy
Graduate Examination Commission (FPGEC)" certificate, and by establishing
proficiency in spoken English by obtaining the score required by rule 4729-5-34
of the Administrative Code on the "Test of Spoken English (TSE)".
(C) The
term "United States," as used in paragraph (B) of this rule, shall be
deemed to include all states of the United States, the District of Columbia,
and all territories and any commonwealths.
4729-5-13 Prescription
format.
Except
as provided in rule 4729-5-14 of the Administrative Code:
(A) No
pharmacist shall dispense dangerous drugs pursuant to a written outpatient
prescription unless the following conditions are met:
(1) The
prescription is issued in compliance with rule 4729-5-30 of the Administrative
Code.
(2) If
preprinted with multiple drug name and strength combinations:
(a) There
are no controlled substances among the choices;
(b) There
is only one prescription order selected per form.
(B) No prescriber shall write and no pharmacist shall
dispense controlled substances pursuant to a written outpatient prescription
unless the following conditions are met:
(1) The
prescription has been issued in compliance with rule 4729-5-30 of the
Administrative Code.
(2) The
prescription contains only one prescription order per prescription form,
whether handwritten or preprinted.
(3) The
quantity has been written both numerically and alphabetically.
(4) If
preprinted, there is only one drug and strength combination printed on the
form.
(C) A prescription issued
by a medical intern, resident, or fellow as defined in paragraph (B) of rule
4729-5-15 of the Administrative Code may not be dispensed unless the
prescription is issued in compliance with this rule and rule 4729-17-13 of the
Administrative Code and unless it bears the identification number issued by
the employing hospital or institution pursuant to rule 4729-17-13 of the
Administrative Code.
(D) A
prescription issued by a staff prescriber of a hospital may not be dispensed
unless the prescription is issued in compliance with this rule and rule
4729-17-13 of the Administrative Code and unless it bears the identification
number issued by the employing hospital or institution pursuant to rule
4729-17-13 of the Administrative Code.
(E) If
a board-approved electronic prescription transmission system is used to fax a
prescription to a pharmacy, the faxed order is exempt from paragraphs (A) and
(B) of this rule. The faxed order must
comply with rule 4729-5-30 of the Administrative Code and must be filed in the
most restrictive file according to rule 4729-5-09 of the Administrative Code.
4729-5-24 Prescription
copy.
(A) A
pharmacist may transfer a copy of a prescription; a pharmacist may refill a
copy of a prescription; such actions must be in accordance with the following:
(1) Copies
of prescriptions shall be transferred only between pharmacists; copies of prescriptions
for controlled substances pursuant to sections 3719.41, 3719.43, and 3719.44 of
the Revised Code shall be communicated directly between two pharmacists and
shall be transferred only one time.
However, pharmacies electronically sharing a real-time, on-line
database may transfer a controlled substance prescription up to the maximum
number of refills permitted by law and the prescriber's authorization pursuant
to paragraph (A)(4) of this rule.
(2) The
copy transferred shall be an exact duplicate of the original prescription
except that it shall also include:
(a) Serial
prescription number assigned to the prescription;
(b) Name
and address (and "D.E.A." number for controlled substance
prescriptions) of the pharmacy transferring the copy;
(c) Date of issuance of the prescription;
(d) Date of original dispensing of the prescription;
(e) Original
number of refills;
(f) Date
of last refill;
(g) Number
of valid refills remaining; and
(h) The
full name of the transferring pharmacist.
(3) Copies
transferred for non-refillable prescriptions shall be marked on the face of the
prescription or orally noted by the transferring pharmacist "For
Information Purposes Only" and are not valid prescriptions for the
dispensing of drugs.
(4) The pharmacist transferring a copy of a
prescription must:
(a) Cancel
the original prescription by writing the word "void" on the face of
the prescription in such a way as to avoid destroying any of the original
information contained on the prescription;
(b) Record
on the reverse side of the original written prescription:
(i) Date
of transfer;
(ii) His/her
signature; and
(iii) When
transferring an oral prescription, the name and address (and "D.E.A."
number for controlled substance prescriptions) of, and name of the pharmacist
at, the receiving pharmacy.
(c) Except,
if an automated data processing system is being used as an alternate system of
recordkeeping for prescriptions pursuant to rules 4729-5-27 and 4729-5-28 of
the Administrative Code, copies of prescriptions may be transferred by a
pharmacist if the prescription record in the system is invalidated to prevent
further dispensing at the original site.
The prescription record in the system must contain the date of
transfer, name of pharmacist making transfer, and the name and address of the
pharmacy receiving the copy. Also,
original written prescriptions for controlled substances must be canceled as
required in paragraphs (A)(4)(a) and (A)(4)(b) of this rule.
(5) The
pharmacist receiving a copy of a prescription must:
(a) Exercise
reasonable diligence to determine validity of the copy;
(b) Reduce
an oral prescription to writing by recording all of the information transferred
(must include all information required in paragraph (A)(2) of this rule) and
write the word "transfer" on the face of the prescription;
(c) Record
date of transfer on the face of the prescription.
(B) A
prescription copy may be transferred between two pharmacies if the two pharmacies
are accessing the same prescription records in a centralized database or
pharmacy computers linked in any other manner.
The computerized systems must satisfy all information requirements of
paragraphs (A)(2) and (A)(4)(c) of this rule.
This shall include invalidation of the prescription record in the system
to prevent further dispensing at the original site and, if a controlled
substance prescription, the canceling of the original written prescription as
required in paragraphs (A)(4)(a) and (A)(4)(b) of this rule. A system must be in place that will allow
only authorized access to these computerized prescription records by a
pharmacist and indicate on the prescription record when and by whom such
access was made.
(C) A
prescription copy may be transferred between two pharmacists by the use of a
facsimile machine. This facsimile may
be considered to be a copy of a prescription if all information requirements of
paragraph (A) of this rule, including invalidation of the original prescription
or computer records, are met. A system
must be in place that will show on the facsimile positive identification of the
transferring and receiving pharmacists which must become a part of the
prescription record. Facsimile copies
must be recorded in writing pursuant to section 4729.37 of the Revised Code, or
stored in such a manner that will allow retention of the prescription record
for three years from the date of the last transaction.
(D) Information
on a prescription is the property of the patient and is intended to authorize
the dispensing of a specific amount of medication for use by the patient. Original copies of prescriptions shall be
maintained by pharmacies for the purpose of documenting the dispensing of drugs
to a particular patient.
(1) In the event that the
pharmacy is not able to provide the medication when needed by the patient
pursuant to an authorized refill, the pharmacist shall, upon the request of
the patient, transfer the prescription information to the pharmacy designated
by the patient.
(2) No
pharmacy shall refuse to transfer information about a previously dispensed
prescription to another pharmacy when requested by the patient. Prescription information shall be
transferred in accordance with this rule as soon as possible in order to assure
that the patient’s drug therapy is not interrupted.
(E) Prescriptions
entered into a computer system but not dispensed may be transferred to another
pharmacy if all of the following conditions are met:
(1) The
complete prescription information has been entered into the computer system;
(2) The
information is displayed on the patient’s profile;
(3) There
is positive identification, either in the computer system or on the hard-copy
prescription, of the pharmacist who is responsible for entering the
prescription information into the system;
(4) The
original prescription is filed in accordance with rule 4729-5-09 of the
Administrative Code;
(5) All
requirements of this rule are met for the transfer of the prescription.
(F) Transfer
of prescription information between two pharmacies which are accessing the
same real-time, on-line database pursuant to the operation of a board-approved
central filling operation shall not be considered a prescription copy and,
therefore, is not subject to the requirements of this rule.
4729-5-27 Recordkeeping.
The
following recordkeeping requirements do not apply to records relating to the
practice of pharmacy for an inpatient as defined in rule 4729-17-01 of the
Administrative Code.
(A) There
must be positive identification of the pharmacist or pharmacists responsible
for performing all activities relating to the practice of pharmacy including,
but not limited to:
(1) Prescription
information entered into the recordkeeping system;
(2) Prospective
drug utilization review as defined in rule 4729-5-20 of the Administrative
Code;
(3) Dispensing;
(4) Patient
counseling;
(5) Administering adult immunizations;
(6) Prescription
information reduced to writing from an order received by telephone, facsimile,
or recording device.
(B) When
a pharmacist dispenses a drug pursuant to an original prescription, he/she
must record the date of such dispensing and either manually record his/her name
or initials on the original prescription or, if approved by the state board of
pharmacy, enter his/her positive identification into the computerized
recordkeeping system as required in rule 4729-5-28 of the Administrative
Code. If an alternate recordkeeping
system is being used pursuant to this rule, the record of dispensing the
original prescription must also be recorded in the alternate recordkeeping
system.
(C) When
a pharmacist dispenses a drug pursuant to an authorized refill of a prescription,
he/she must record the date of such dispensing and manually record his/her name
or initials on the original prescription or enter such information on an
alternate record meeting the requirements of this rule. If an alternate recordkeeping system is being
used pursuant to this rule, this alternate record must be used to record the
dispensing of all prescriptions.
(D) The
quantity dispensed shall be considered the quantity prescribed unless:
(1) If
the quantity dispensed on a new prescription is less than the quantity
prescribed, the pharmacist shall note the quantity dispensed on the original
prescription. If the quantity dispensed
on a new prescription is greater than the quantity prescribed, the pharmacist
shall also record on the original prescription the name of the authorizing
prescriber, the full name of the agent of the prescriber if applicable, the
quantity authorized to be dispensed, and the date and time that the prescriber
was contacted and approval authorization was obtained.
(2) If
the quantity dispensed on a refill prescription is less than the quantity
prescribed, the pharmacist shall note the quantity dispensed on the original
prescription or enter the quantity dispensed on an alternate record meeting the
requirements of this rule. If the
quantity dispensed on a refill prescription is greater than the quantity prescribed,
the pharmacist shall also record the name of the authorizing prescriber, the
full name of the agent of the prescriber if applicable, the quantity authorized
to be dispensed, and the date and time that the prescriber was
contacted and approval authorization was obtained.
(E) Where
a prescription is written using a generic name, or where the pharmacist
dispenses an equivalent drug product pursuant to the provisions of sections
4729.38 and 4729.381 of the Revised Code, the brand name or drug name and name
of the manufacturer or distributor of the drug or the national drug code (NDC)
number of the drug dispensed must be recorded on the record of dispensing by
the pharmacist.
(F) Records
of dispensing drugs must provide accountability and ensure that patients do not
receive more drugs than intended by the prescriber. All recordkeeping systems shall provide records which are readily
retrievable and uniformly maintained for a period of three years from the date
of the last dispensing.
(G) If
an alternate recordkeeping system is being used pursuant to this rule, such
record shall include at a minimum the following data:
(1) The
serial number assigned to and recorded on the original prescription preserved
on file at the pharmacy in accordance with section 4729.37 of the Revised Code.
(2) Name,
strength, and dosage form of the drug dispensed.
(3) Date
of dispensing (filling or refilling).
(4) Quantity
dispensed. If the quantity dispensed is
greater than that prescribed, the pharmacist must record the date and time that
he/she contacted the prescriber and obtained approval.
(5) The
positive identification of the dispensing pharmacist.
(H) All
records relating to the practice of pharmacy shall be readily available, and
promptly produced, upon request for inspection by a state board of pharmacy
officer, agent, and/or inspector during regular business hours.
(I) All
prescriptions or other records relating to the practice of pharmacy, which are
required to be kept for three years according to section 4729.37 of the
Revised Code, may be microfilmed or placed on electronic, magnetic media. The microfilm or electronic, magnetic media
used for this purpose must comply with the "International Standards
Organization" standards of quality approved for permanent records. Such records are subject to all other
paragraphs of this rule.
(J) Any pharmacy
intending to maintain records relating to the practice of pharmacy at a
location other than the place licensed with the state board of pharmacy must
first send written notification to the state board of pharmacy by certified
mail, return receipt requested or facsimile. If not contested within sixty days of
receipt by the The state board of pharmacy office, such
request will stand as approved send written notification of the
approval or disapproval of the request.
Only after receiving the notice of the board's approval may the
records be placed in the new location.
(K) Records
shall be maintained for three years on all adult immunizations administered
pursuant to section 4729.41 of the Revised Code and must include at least the
following information:
(1) Full name and address of the
patient;
(2) Patient’s date of birth or
age;
(3) Patient’s gender;
(4) Patient’s
applicable allergy information;
(5) Date
of administration by the pharmacist;
(6) Name,
strength, and dose of the adult immunization administered;
(7) Lot number and expiration date of the
immunization;
(8) Route
of administration;
(9) Location
of the injection site;
(10) Positive
identification of the administering pharmacist;
(11) Documentation
of patient informed consent.
(L) A
pharmacist who administers adult immunizations pursuant to section 4729.41 of
the Revised Code shall maintain and immediately make available, upon the
request of the state board of pharmacy, the following records:
(1) Documentation
of the successful completion of a board-approved course in the administration
of adult immunizations;
(2) Documentation
of the certification to perform basic life-support procedures pursuant to
division (B)(2) of section 4729.41 of the Revised Code.
4729-5-29 Confidentiality
of patient records.
(A) Records
relating to the practice of pharmacy or administering of drugs are not a public
record. A person having custody of, or
access to, such records shall not divulge the contents thereof, or provide a
copy thereof, to anyone except:
(1) The patient for whom the
prescription or medication order was issued.
(2) The prescriber who issued
the prescription or medication order.
(3) Certified/licensed
health care personnel who are responsible for the care of the patient.
(4) A
member, inspector, agent, or investigator of the state board of pharmacy or
any federal, state, county, or municipal officer whose duty is to enforce the
laws of this state or the United States relating to drugs and who is engaged in
a specific investigation involving a designated person or drug.
(5) An
agent of the state medical board when enforcing Chapter 4731. of the Revised
Code.
(6) An
agency of government charged with the responsibility of providing medical care
for the patient upon a written request by an authorized representative of the
agency requesting such information.
(7) An
agent of a medical insurance company who provides prescription insurance
coverage to the patient upon authorization and proof of insurance by the
patient or proof of payment by the insurance company for those medications
whose information is requested.
(8) An agent who
contracts with the pharmacy as a "business associate" in accordance
with the regulations promulgated by the secretary of the United States department
of health and human services pursuant to the federal standards for privacy of
individually identifiable health information.
(9) Any
person, other than those listed in paragraphs (A)(1) to (A)(7) (A)(8)
of this rule, only when the patient has given consent for such disclosure in
writing, except where a patient requiring medication is unable to deliver a
written consent to the necessary disclosure.
Any consent must be signed by the patient and dated. Any consent for disclosure is valid until rescinded
by the patient. In an emergency, the
pharmacist may disclose the prescription information when, in the professional
judgment of the pharmacist, it is deemed to be in the best interest of the
patient. A pharmacist making an oral
disclosure in an emergency situation must prepare a written memorandum showing
the patient's name, the date and time the disclosure was made, the nature of
the emergency, and the names of the individuals by whom and to whom the
information was disclosed.
(B) Any
Testimonial privilege is not waived for any communication between a
physician, a pharmacist, and a patient, pursuant to a consult
agreement, except when requested by a federal, a state, or a local government
entity, is privileged from discovery or other use and disclosure in civil
process section 2317.02 of the Revised Code.
(C) Records relating to
the practice of pharmacy or administering drugs which may be required as
evidence of a violation shall be released to a member, inspector, agent, or
investigator of the state board of pharmacy or any state, county, or municipal
officer whose duty is to enforce the laws of this state or the United States
relating to drugs and who is engaged in a specific investigation involving a
designated person or drug upon his request.
Such person shall furnish a receipt to the person having legal custody
of the records. If the record is a
prescription, the receipt shall list the following information:
(1) Prescription
identification number; or, if an order for medication, the name of the patient;
(2) The
drugs prescribed;
(3) Quantity
of drugs prescribed and dispensed;
(4) Name
of the prescriber;
(5) Date,
name of agency, and signature of person removing the records.
(D) All
such records, including consents, memoranda of emergency disclosures, and
written requests pursuant to paragraph (A)(8) (A)(9) of this
rule, shall be kept on file at the pharmacy for a period of three years in a
readily retrievable manner.
4729-5-30 Manner of
issuance of a prescription.
(A) A prescription, to be
valid, must be issued for a legitimate medical purpose by an individual
prescriber acting in the usual course of his/her professional practice. The responsibility for the proper
prescribing is upon the prescriber, but a corresponding responsibility rests
with the pharmacist who dispenses the prescription. An order purporting to be a prescription issued not in the usual
course of bona fide treatment of a patient is not a prescription and the
person knowingly dispensing such a purported prescription, as well as the
person issuing it, shall be subject to the penalties of law.
(B) All
prescriptions issued by a prescriber shall:
(1) Be
dated as of and on the day when issued.
(2) Indicate
the full name and address of the prescriber.
(3) Indicate
the full name and address of the patient.
(4) Indicate
the drug name and strength.
(5) Indicate
the quantity to dispense.
(6) Indicate
the appropriate directions for use.
(7) Specify the number of times or the period of time
for which the prescription may be refilled.
If no such authorization is given, the prescription may not be refilled
except in accordance with section 4729.281 of the Revised Code. A prescription marked "Refill
P.R.N." or some similar designation is not considered a valid refill
authorization.
(8) Not
authorize any refills for schedule II controlled substances.
(9) Authorize
refills for schedules III and IV controlled substances only as permitted by
section 3719.05 of the Revised Code.
(10) Not
authorize a refill beyond one year from the date of issuance for schedule V
controlled substances and for dangerous drugs that are not controlled
substances.
(11) Identify
the trade name or generic name of the drug(s) in a compounded prescription.
(12) Not
be coded in such a manner that it cannot be dispensed by any pharmacy of the
patient's choice.
(13) For
prescriptions issued to a patient by a prescriber, be:
(a) Manually
signed on the day issued by the prescriber in the same manner as he/she would
sign a check or legal document.
(b) Issued
in compliance with rule 4729-5-13 of the Administrative Code.
(14) Be
issued in compliance with all applicable federal and state laws, rules, and
regulations.
(C) When forms are used that create multiple copies
of a prescription issued to a patient by a prescriber, the original
prescription that bears the actual signature of the prescriber must be issued
to the patient for dispensing by a pharmacist.
(D) A
pharmacist may not dispense a dangerous drug for the first time beyond six
months from the date of issuance of a prescription.
(E) Oral
transmission by the prescriber or the prescriber’s agent of original
prescriptions and refills authorized by a prescriber, pursuant to the
requirements of this rule, may be transmitted by telephone only to:
(1) A
pharmacist. The prescriber or
prescriber’s agent must provide his/her full name. The pharmacist shall make a record of the prescriber's agent on
the original prescription and, if used, on the alternate system of
recordkeeping. The pharmacist is
responsible for assuring the validity of the source of the oral prescription.
(2) A
recording device within the pharmacy if the pharmacist is unavailable. The prescriber or prescriber's agent must
provide his/her full name. The
pharmacist must remove the prescription from the recorder and reduce it to
writing. The pharmacist is responsible
for assuring the validity of the prescription removed from the recorder.
(3) A
licensed pharmacy intern if the pharmacist on duty who is supervising the
activity of the intern determines that the intern is competent to receive
telephone prescriptions.
(a) The
intern shall immediately reduce the prescription to writing and shall review
the prescription with the supervising pharmacist. Prior to dispensing, positive identification of the intern and
the supervising pharmacist shall be made on the prescription to identify the
responsibility for the receipt of the oral order.
(b) The
supervising pharmacist on duty is responsible for the accuracy of the
prescription.
(c) The
supervising pharmacist on duty must be immediately available to answer
questions or discuss the prescription with the caller.
(F) Original
written prescriptions authorized and signed by a prescriber may be transmitted
by the prescriber or the prescriber’s agent by facsimile machine to a pharmacy
pursuant to the following:
(1) The prescription must be issued in compliance
with this rule.
(2) The original
prescription signed by the prescriber from which the facsimile is produced
shall not be issued to the patient. The
original prescription signed by the prescriber must remain with the patient’s
records at the prescriber’s office or the institutional facility where it was
issued.
(3) Such
a facsimile shall only be valid as a prescription if a system is in place that
will allow the pharmacist to maintain the facsimile as a part of the
prescription record including the positive identification of the prescriber and
his/her agent as well as positive identification of the origin of the
facsimile.
(4) The
pharmacist must record the prescription in writing pursuant to section 4729.37
of the Revised Code or store the facsimile copy in such a manner that will
allow retention of the prescription record for three years from the date of the
last transaction.
(5) Prescriptions
for schedule II controlled substances may not be transmitted by facsimile
except:
(a) Pursuant
to rules 4729-17-09 and 4729-19-02 of the Administrative Code.
(b) For
a narcotic substance issued for a patient enrolled in a hospice. The original prescription must indicate that
the patient is a hospice patient. The
facsimile transmission must also meet the other requirements of this rule.
(6) A
facsimile of a prescription received by a pharmacy in any manner other than
transmission directly from the prescriber or the prescriber’s agent shall not be
considered a valid prescription, except as a copy of a prescription pursuant
to rule 4729-5-24 of the Administrative Code.
(G) A prescription may be
transmitted by means of a board-approved electronic prescription transmission
system, without further verification by the pharmacist of the prescriber’s
identity, provided that:
(1) The
system shall require positive identification of the prescriber as defined in
rule 4729-5-01 of the Administrative Code and the full name of any authorized agent
of the prescriber who transmits the prescription.
(2) The
computer data must be retained for a period of three years at the prescriber's
office.
(H) A
pharmacist who modifies a patient's drug therapy pursuant to a consult
agreement and:
(1) Is
also responsible for the dispensing of the drug to the patient must include on
the drug order the name of the physician who originally prescribed the drug,
sign the pharmacist's full name, and be in compliance with this rule in the
same manner as the prescriber.
(2) Is
not responsible for the dispensing of the drug to the patient may transmit the
order to a pharmacy by acting as an agent of the physician. Such pharmacist must personally transmit the
order verbally or by facsimile to another pharmacist and be in compliance with
this rule.
4729-6-01 Definitions;
impaired pharmacists.
As
used in Chapter 4729-6 of the Administrative Code:
(A) "Substance
abuse/chemical dependency" means a condition involving the use of alcohol
or other drugs to a degree that it interferes in the functional life of the
licensee, as manifested by physical health, family, job, legal, financial, or
emotional/psychiatric problems.
(B) "Impaired
pharmacist" means a pharmacist who, because of his/her use of psychoactive
substances, is unable to practice pharmacy with requisite judgment, skill,
competence, or safety to the public.
(C) "Approved
treatment provider" means a board approved and designated treatment
program pursuant to section 4729.18 of the Revised Code and Chapter 4729-6 of
the Administrative Code that has been certified by the Ohio department of
alcohol and drug addiction services (ODADAS) pursuant to division (A) of section
3793.06 of the Revised Code and who provides or has contractual arrangements
to provide all of the following services: to identify, verify, assess the
degree of impairment, detoxify, rehabilitate, and monitor the impaired
pharmacist.
(D) "Limited
approved treatment provider" means a board approved and designated
treatment program pursuant to section 4729.18 of the Revised Code and Chapter
4729-6 of the Administrative Code who provides or has contractual arrangements
to provide identification and referral services for the impaired pharmacist
and may provide monitoring during rehabilitation.
(E) "Intervenor"
means a person who participates in a process whereby a pharmacist alleged to
be impaired is confronted to evaluate the presence of impairment and, if
indicated, who refers the pharmacist for assessment and treatment of the problem.
(F) "Referral
for assessment" means a process whereby an intervenor who has reason to
believe that a pharmacist is impaired directs that individual to be examined
for diagnosis and treatment.
(G) "Treatment
assessor" means an individual who is licensed under Chapter 4731. of the
Revised Code as a doctor of medicine or a doctor of osteopathic medicine and
surgery and who is a certified addictionist or an individual who is certified
by the Ohio department of alcohol and drug addiction services (ODADAS) as a
certified chemical dependency counselor 3 or 2 pursuant to section 3793.07 of
the Revised Code and Chapter 3793:2 of the Administrative Code and who by
training and experience can make an assessment of a pharmacist's impairment.
(H) "Individualized
treatment plan" is a written document which shall provide for inpatient
treatment, outpatient treatment, family therapy, psychotherapy, professional
support groups, twelve-step programs, aftercare including support and
self-help groups, monitoring programs consisting of random, chain of evidence
drug screens, and work site review. The
above services and other services may be determined by an approved treatment
provider.
(I) "Treatment
contract" means the document which outlines the individualized treatment
plan, the requirement to cease practice, the requirement for compliance by the
impaired pharmacist, and the requirement for notification of the board for
non-compliance or relapse pursuant to section 4729.18 of the Revised Code.
(J) "Inpatient
treatment" shall consist of placing the pharmacist in an approved
treatment provider facility that will provide lodging and food, as well as care
and treatment for detoxification and rehabilitation as indicated by the
treatment contract.
(K) "Outpatient
treatment" shall consist of the pharmacist not residing in an inpatient
treatment facility but who is participating in aftercare, twelve-step programs,
professional support group (if available), and monitoring programs consisting
of random, chain of evidence drug screens and work site review, to establish
compliance for a minimum of two years.
(L) "Responsible
person" for an approved treatment provider or limited approved treatment
provider is an individual who shall be in full and actual charge of the
treatment program; including but not limited to, having a current license as an
approved treatment provider or limited approved treatment provider, assuring
the provider has the necessary facilities and personnel to provide services,
maintaining records, and notification of the board when required.
(M) "Twelve-step
program" is a self-help program such as Alcoholics Anonymous or Narcotics
Anonymous which the individual shall be required to personally
attend. The minimum attendance required
shall not be less than three documented meetings each week during the first
two years in recovery.
(N) "Aftercare"
is a counselor-facilitated group meeting which directly responds to problems
relating to the ongoing treatment and monitoring of the pharmacist's sobriety,
and should extend for a minimum of six months.
(O) "Professional
support group" is a group of peers meeting to discuss the problems
peculiar to recovery and re-entry to practice of the licensed professional.
(P) "Relapse"
means a positive drug screen or a return to a pattern of impairment activities
which affects the pharmacist's ability to practice.
4729-6-02 Applicability.
(A) No
person, except a licensed approved treatment provider, shall purport to be or
operate as a treatment facility for the purpose of administering care in the
detoxification and rehabilitation of an impaired pharmacist.
(B) The
rules in Chapter 4729-6 of the Administrative Code are applicable to all
licensed pharmacists, pharmacy interns, and any other board licensees. For the purposes of this chapter only, the
word "pharmacist" shall include pharmacy interns and other persons
individuals licensed by the board.
(C) Should
the board have reason to believe that a pharmacist suffers from impairment
because of conduct or behavior committed or displayed by the pharmacist, the
board may compel the individual to be examined by an approved treatment
provider. If the pharmacist fails to
submit to an assessment as ordered by the board, or if the assessment discloses
impairment, or if there is an admission of impairment, or if the board has
other reliable, substantial, and probative evidence demonstrating impairment,
the board may:
(1) Refer
the licensee for treatment;
(2) Initiate
action against the licensee pursuant to Chapter 119. of the Revised Code;
(3) Summarily
suspend the license of a pharmacist pursuant to rule 4729-6-10 of the
Administrative Code if the licensee's continued practice poses a danger of
immediate and serious harm to others.
(D) Before being eligible to apply for reinstatement
of a license suspended because of impairment, the pharmacist must demonstrate
to the board that he/she possesses the requisite judgment, skill, and
competence to ensure public safety in the practice of pharmacy. Such demonstration shall include but not be
limited to the following:
(1) Certification from an approved treatment provider
that the pharmacist:
(a) Has
signed a treatment contract and is participating in and complying with an individualized
treatment plan;
(b) Has
successfully completed the required inpatient treatment;
(c) Is actively participating in an outpatient
treatment program;
(d) Has
been shown to be alcohol and drug free by random, chain of evidence drug
screens for a period of time as determined by the board at the time of the
suspension;
(e) Has
been evaluated by an approved treatment provider who has made a clear
determination, documented in a written statement, that the pharmacist is
capable of practicing.
(2) Certification that the pharmacist has met all
requirements of the board order and satisfactory evidence has been submitted to
the board, including but not limited to:
(a) A
copy of the signed and agreed to treatment contract;
(b) Written
reports and documentation from the approved treatment program;
(c) Written
reports from the pharmacist describing progress towards recovery.
4729-6-08 Requirements
for approved treatment providers and limited approved treatment providers.
(A) An
intervenor associated with either an approved treatment provider or a limited
approved treatment provider shall:
(1) Respond
to information from concerned individuals;
(2) Ascertain
validity of the information received;
(3) Assess
the situation and, if the pharmacist is showing evidence of impairment, the
intervenor shall refer the individual for examination;
(4) If
the pharmacist fails to comply within one week to a referral for examination,
the intervenor must report the name of the pharmacist to the board of pharmacy by
phone within one working day and follow with a written report within two
working days.
(B) A
treatment assessor associated with an approved treatment provider shall examine
a pharmacist referred to the approved treatment provider to determine if the
pharmacist has a substance abuse/chemical dependency related impairment.
(C) If such an impairment
exists, the approved treatment program shall formulate the pharmacist's
individualized treatment plan as defined in rule 4729-6-01 of the
Administrative Code. The specific
requirements shall be determined by an assessment of psychological, physical,
developmental, family, social, environmental, recreational, and professional
needs. The individualized treatment
plan shall be part of a treatment contract which the impaired pharmacist must
sign. If the impaired pharmacist fails
to sign the treatment contract and enter treatment within forty-eight hours of
the determination that the pharmacist needs treatment, the approved treatment
provider must report the name of the pharmacist to the board of pharmacy by
phone within one working day and follow with a written report within two
working days.
(D) The
responsible person for the approved treatment provider shall:
(1) Establish
a system of records that will provide for complete information about an
impaired pharmacist from intervention through the rehabilitation stage;
(2) Establish
treatment contracts meeting the requirements of this chapter and a system of
follow up to determine compliance by the impaired pharmacist with the treatment
contract;
(3) Assure
confidentiality of the impaired pharmacist, except:
(a) If
the pharmacist fails to comply within one week to a referral for examination,
(b) If
the impaired pharmacist fails to sign the contract and enter treatment within
forty-eight hours of the determination that the pharmacist needs treatment,
(c) If
the impaired pharmacist does not suspend practice on entering treatment,
(d) If
the impaired pharmacist does not comply with the terms of the treatment
contract,
(e) If
the impaired pharmacist resumes practice before the approved treatment provider
has made a clear determination that the pharmacist is capable of practicing,
(f) If
the impaired pharmacist suffers a relapse at any time during or following
rehabilitation.
(4) Notify
the board of pharmacy by phone within one working day and follow with
a written report within two working days if the pharmacist violates any
portion of this rule.
(E) The responsible person for the limited approved
treatment provider shall:
(1) Assure confidentiality of the impaired
pharmacist, except:
(a) If the pharmacist fails to comply within one week
to a referral for examination, or,
(b) If
the impaired pharmacist suffers a relapse at any time during or following
rehabilitation.
(2) Notify the board of pharmacy by phone
within one working day and follow with a written report within two working
days if the pharmacist violates any portion of this rule.
4729-7-02 Requirements
for renewal of a pharmacist identification card.
(A) Except as provided in
rule 4729-7-08 of the Administrative Code, evidence of four and one-half
six C.E.U.s of approved continuing education shall be submitted with
the application for renewal of a pharmacist identification card by the
date indicated on the continuing pharmacy education report form and at
intervals not to exceed three years. At
least 0.3 C.E.U.s of the total required C.E.U.s must be obtained from Ohio
state board of pharmacy approved programs in jurisprudence. Beginning with those pharmacists required
to report continuing education in 2001, evidence of six C.E.U.s of approved
continuing education shall be submitted with the application for renewal of a
pharmacist identification card at intervals not to exceed three years. Beginning with those pharmacists required to
report continuing education in 2001, at least four and one-half C.E.U.s of the
total required C.E.U.s must be obtained in patient care related programs and
at least 0.3 C.E.U.s of the total required C.E.U.s must be obtained from board
approved programs in jurisprudence.
(B) Documentation
of the required C.E.U.s shall be submitted on forms provided by the state board
of pharmacy and in the manner required for renewal of the pharmacist
identification card.
(C) The
C.E.U.s must be obtained on or after July first of the year that is three years
prior to the year in which evidence of the continuing pharmacy education is
required for identification card renewal.
Beginning with those pharmacists required to report continuing
education in 2004, as long as the continuing pharmacy education report forms
are filed in a timely manner, the C.E.U.s must be obtained on or after March
first of the year that is three years prior to the year in which evidence of
the continuing pharmacy education is required for identification card
renewal. If the continuing pharmacy
education report forms are not filed in a timely manner, the C.E.U.s must have
been obtained during the three-year period immediately preceding the date that
the continuing pharmacy education report form is filed.
(D) C.E.U.s
obtained in excess of the required C.E.U.s at the time the continuing education
is required for identification card renewal may not be transferred and applied
to future requirements.
(E) A
pharmacist whose identification card has lapsed or has been suspended may renew
his/her identification card, if he/she qualifies for renewal pursuant to
section 4729.12 or section 4729.13 of the Revised Code, by paying the required
fee, completing the application for renewal, and, if he/she would have been
required to report continuing pharmacy education during the period of lapse or
suspension, by providing evidence of having obtained the number of C.E.U.s
required at the time of renewal by submitting the certificates of participation
obtained during the three‑year period immediately preceding the date of
applying for renewal.
(F) Ohio-registered
pharmacists who hold a current license in states where continuing education is
mandatory, have met the continuing pharmacy education requirements of that
state, and who do not practice pharmacy in Ohio, may renew their identification
card by paying the required fee, completing the application for renewal, and
submitting the following signed statement on their continuing pharmacy
education report form:
"I
declare under penalties of falsification that I hold a current and valid pharmacist
license, number (insert license number), in the state of (insert name of
state), that I have met the continuing pharmacy education requirements of this
state and I do not presently practice pharmacy in the state of Ohio. I hereby agree to immediately notify the
Ohio state board of pharmacy if I return and commence the practice of pharmacy
in the state of Ohio."
4729-9-04 Returned
drugs.
(A) No
drug that has been dispensed pursuant to a prescription and has left the
physical premises of the terminal distributor of dangerous drugs shall be
dispensed again except:
(1) Drugs
dispensed for inpatients pursuant to paragraph (C) of rule 4729-17-01 of the
Administrative Code, or provided that:
(a) The
drugs are packaged in unopened, single-dose or tamper-evident containers and
(b) The
drugs have not been in the possession of the ultimate user.
(2) Non-controlled
drugs dispensed by a government entity and delivered for outpatients to a
psychiatric outpatient facility licensed with the state board of pharmacy
provided that:
(a) The drugs are packaged in unopened, single-dose
or tamper-evident containers and
(b) The
drugs have not been in the possession of the ultimate user.
(B) Drugs
that have not been dispensed or possessed in accordance with this rule are
considered to be adulterated.
4729-10-02 Licensure.
Each nonresident
terminal distributor of dangerous drugs that sells dangerous drugs at retail
in the state of Ohio shall obtain a terminal distributor of dangerous drugs
license pursuant to sections 4729.54 and 4729.55 of the Revised Code and
Chapter 4729-10 of the Administrative Code.
(A) Conditions of
licensure. The nonresident terminal distributor of dangerous drugs shall
provide the following information relative to the qualifications of a terminal
distributor of dangerous drugs set forth in section 4729.55 of the Revised
Code:
(1) Full name, address, and
telephone number of the person who desires to be licensed as a nonresident
terminal distributor of dangerous drugs.
(a) If incorporated, the
application for licensure must include copies of the incorporation papers; and
names, dates of birth, addresses, and social security numbers of the officers
of the corporation and all stockholders holding more than ten percent of the
stock.
(b) If a proprietorship, the application for
licensure must include the name, address, date of birth, and social security
number of the owner(s).
(c) If a partnership, the application for licensure
must include the names, addresses, dates of birth, and social security numbers
of the partners.
(d) If
the entity applying for a license is a private investment group, the
application for licensure must include the names, addresses, dates of birth,
and social security numbers of the investors.
(2) Certification
from the appropriate licensing authority that the applicant maintains at all
times a valid, unexpired license, permit, or registration to properly carry on
the business of a distributor of dangerous drugs in the state in which the
facility is located and from where dangerous drugs are being sold at retail to
residents in Ohio. The certification(s) must include licenses, permits,
or registrations required to cover the categories of dangerous drugs which the
nonresident terminal distributor of dangerous drugs will be selling at retail
to persons in the state of Ohio (i.e., controlled substance drug products as
well as noncontrolled substance drug products).
(3) A
copy of the most recent inspection report, any warning notices, notice of
deficiency reports, or any other related reports issued by the regulatory
licensing agency and drug law enforcement agencies of the state in which it is
located or any federal agencies regulating and enforcing laws governing the
legal distribution of drugs.
(4) A
narrative description of the type of business the nonresident terminal
distributor of dangerous drugs will be carrying on within the category of
licensure requested. The description shall include the type of professional
services that will be provided in accordance with federal and state laws
governing the legal distribution of drugs and professional pharmacy practice.
(5) If
the nonresident terminal distributor is a pharmacy, the application shall be
accompanied by:
(a) The name and license number of the responsible
pharmacist (pharmacist-in-charge).
(b) Certification
from the appropriate licensing authority that the responsible pharmacist’s
license is current and in good standing.
(c) The
telephone number where the responsible pharmacist may be reached during normal
business hours.
(d) A
list of all pharmacists employed by the pharmacy who are dispensing dangerous
drugs pursuant to prescriptions to residents of this state. The list
shall include each pharmacist’s license number and the date that the license
will expire.
(e) A description of the following:
(i) Normal delivery protocols and times;
(ii) Any
special packaging or procedures used in delivering temperature-sensitive drug
products;
(iii) The
procedure to be followed if the patient’s prescription drug is not available
at the nonresident pharmacy, or if delivery will be delayed beyond the normal delivery
time;
(iv) The procedure
to be followed upon receipt of a prescription for an acute illness that assures
the patient the opportunity to obtain the medication immediately.
(v) The
procedure to be followed that will ensure that the patient’s medication therapy
is not interrupted when the nonresident pharmacy has been advised by the
patient or patient’s caregiver that the patient’s prescription medication has
not been received within the normal delivery time.
(6) Nonresident
terminal distributors of dangerous drugs where the responsible person is a
dentist, optometrist, physician, or veterinarian shall submit the following
information with their application:
(a) The
name and license number of the responsible dentist, optometrist, physician, or
veterinarian.
(b) Certification
from the appropriate licensing authority that the responsible person’s license
is current and in good standing.
(c) The
telephone number where the responsible dentist, optometrist, physician, or veterinarian
may be reached during normal business hours.
(d) A
list of all dentists, optometrists, physicians, or veterinarians employed by
the nonresident terminal distributor who are selling dangerous drugs at retail
to residents of this state. The list shall include the license numbers
and the date that the licenses to practice will expire.
(B) Discipline.
(1) In
accordance with Pursuant to the provisions of Chapter 119. of the
Revised Code, the board may deny, revoke, suspend, or refuse to renew a
nonresident terminal distributor license, or may issue a monetary penalty or
forfeiture in accordance with under the provisions of section
4729.57 of the Revised Code:
(a) For
making any false material statements in an application for a license as a nonresident
terminal distributor of dangerous drugs.
(b) For
failure to comply with any provision of Chapter 4729-10 of the Administrative
Code.
(c) For serious misconduct on the part of the
nonresident terminal distributor that results in harm to one or more patients
within Ohio.
(d) If
it determines that the nonresident terminal distributor has been disciplined by
another state or federal agency for serious misconduct that may cause patients
within Ohio to be at risk of harm.
(e) For
ceasing to satisfy the qualifications of a nonresident terminal distributor of
dangerous drugs set forth in section 4729.551 of the Revised Code.
(f) For
any violations enumerated in section 4729.56 or 4729.57 of the Revised Code.
(2) Except
in a case that creates an imminent danger to the public health or safety, prior
to initiating a disciplinary action against a nonresident terminal distributor
under paragraphs (B)(1)(c) and (B)(1)(d) of this rule, the board must file a
complaint against the nonresident terminal distributor with the regulatory or
licensing agency of the state in which the nonresident terminal distributor is
located. The board may initiate its own action to discipline a
nonresident terminal distributor if:
(a) The
regulatory or licensing agency of the state in which the nonresident terminal
distributor is located fails to initiate an action by the sixtieth day after
the date that the board filed the complaint under this rule;
(b) The
regulatory or licensing agency of the state in which the nonresident terminal
distributor is located fails to resolve the complaint within one year after the
date that the complaint was filed; or
(c) The
regulatory or licensing agency of the state in which the nonresident terminal
distributor is located lacks or fails to exercise jurisdiction.
(3) Nothing
in this rule shall require the board to take disciplinary action against the
nonresident terminal distributor if it determines that another state has
already taken suitable action for the same offense.
11:59 a.m.
The Board recessed for lunch.
1:00 p.m.
The Board convened in Room 1919, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio, with the following members present:
Ann D. Abele, R.Ph. (President); Gregory Braylock, R.Ph.; Suzanne R. Eastman, R.Ph.; Robert P. Giacalone, R.Ph.; Lawrence J. Kost, R.Ph.; Nathan S. Lipsyc, R.Ph.; Dorothy S. Teater, Public Member; and James E. Turner, R.Ph.
Mr. Keeley joined the Board to discuss a request for approval of the Texas Tech pharmacist immunization program. After discussion, the request was tabled pending receipt of information documenting the program's compliance with the requirements of the Revised and Administrative Codes.
1:13 p.m.
After a discussion of the draft Minutes from the September 11, 12, 2001 meeting, Mr. Giacalone moved that the Board approve the minutes as amended. The motion was seconded by Mr. Lipsyc and approved by the Board (Aye-6/Nay-0/Abstain-1[Eastman]).
RES. 2002-042 Mr. Benedict presented a request from Richard Adams, R.Ph. asking for a waiver from the requirements of Rule 4729-5-11(A) to allow him to serve as responsible pharmacist at more than one location. After discussion, Mr. Turner moved that the request be approved for a period of one year at the following two locations:
Harrison Community Hospital (02-0034450)
Health Connections Pharmacy (02-0560300)
The motion was seconded by Ms. Eastman and approved by the Board (Aye-7/Nay-0).
RES. 2002-043 Mr. Benedict then presented a request from Andrew Bragalone, R.Ph. asking for an extension to the waiver from the requirements of Rule 4729-5-11(A) previously granted by the Board allowing him to serve as responsible person at more than one location. After discussion, Ms. Eastman moved that the extension request be approved for a two-month period at the following two locations:
UHHS Richmond Heights Hospital (02-1214650)
UHHS Laurelwood Hospital (02-0560300)
The motion was seconded by Mr. Kost and approved by the Board (Aye-7/Nay-0).
RES. 2002-044 Mr. Benedict then discussed exemptions to Rule 4729-5-10 (Pick-up station) with the Board. After discussion, Mr. Turner moved that the Board reaffirm the policy that all mental health facilities and tuberculosis health clinics with acceptable policies in place be granted an exemption from Rule 4729-5-10 and that such agency exemptions do not have to be approved individually by the Board, but may be made by Board staff as appropriate. Further, Mr. Turner moved that this reaffirmation of the previous policy of the Board be posted in the minutes of the Board. The motion was seconded by Mrs. Teater and approved by the Board (Aye-7/Nay-0).
There was no Medical Board Prescribing Committee report from Mr. Benedict as the September meeting was cancelled.
1:21 p.m.
The Board was joined by Assistant Attorney General Sally Ann Steuk for the purpose of conducting an adjudication hearing in accordance with Ohio Revised Code Chapters 119. and 4729. in the matter of David W. White, R.Ph., Cincinnati.
3:21 p.m.
The hearing ended and the record was closed. The Board took a brief recess.
3:45 p.m.
The Board was joined by Assistant Attorney General Sally Ann Steuk for the purpose of conducting an adjudication hearing in accordance with Ohio Revised Code Chapters 119. and 4729. in the matter of Joseph N. Gioiello, R.Ph., Warren.
4:47 p.m.
The hearing ended and the record was closed. The Board took a brief recess.
5:00 p.m.
Mr. Turner moved that the Board go into Executive Session for the purpose of the investigation of complaints regarding licensees and registrants pursuant to Section 121.22(G)(1) of the Revised Code. The motion was seconded by Ms. Eastman and a roll call vote was conducted by President Abele as follows: Braylock-Yes, Eastman-Yes, Giacalone-Yes, Lipsyc-Yes, Kost-Yes, Teater-Yes, and Turner-Yes.
5:20 p.m.
RES. 2002-045 The Executive Session ended and the meeting was opened to the public. Mr. Braylock moved that the Board issue the following Order in the matter of Joseph N. Gioiello, R.Ph.:
ORDER OF THE STATE BOARD OF PHARMACY
(Docket
No. D-010409-062)
In
The Matter Of:
JOSEPH NEIL GIOIELLO, R.Ph.
8550 Bayberry NE
Warren, Ohio 44484
(R.Ph. No. 03-1-17346)
INTRODUCTION
THE MATTER OF JOSEPH NEIL GIOIELLO CAME FOR HEARING
ON OCTOBER 1, 2001, BEFORE THE FOLLOWING MEMBERS OF THE BOARD: ANN D. ABELE,
R.Ph. (presiding); GREGORY BRAYLOCK, R.Ph.; SUZANNE R. EASTMAN, R.Ph.; ROBERT
P. GIACALONE, R.Ph.; LAWRENCE J. KOST, R.Ph.; NATHAN S. LIPSYC, R.Ph.; DOROTHY
S. TEATER, PUBLIC MEMBER; AND JAMES E. TURNER, R.Ph.
JOSEPH NEIL GIOIELLO WAS REPRESENTED BY DAMIAN P.
DeGENOVA AND THE STATE OF OHIO WAS REPRESENTED BY SALLY ANN STEUK, ASSISTANT
ATTORNEY GENERAL.
SUMMARY OF EVIDENCE
(A) Testimony
State's
Witnesses:
(1) None
Respondent's
Witnesses:
(1) Joseph Neil Gioiello, R.Ph., Respondent
(2) Todd Jaros, R.Ph.
(B) Exhibits
State's
Exhibits:
(1) Exhibit 1--Hearing Request letter from
Joseph N. Gioiello dated March 30, 2001.
(2) Exhibit 1A--Copy of Hearing Schedule letter dated and
postmarked April 9, 2001.
(3) Exhibit 1B--Copy of Hearing Schedule letter dated April 9, 2001
and postmarked April 12, 2001.
(4) Exhibit 1C--Copy of Hearing Schedule letter dated May 17, 2001.
(5) Exhibit 1D--Copy of Ohio Pharmacist Computer Record of Joseph
Neil Gioiello.
(6) Exhibit 1E--Notice of Counsel letter from Damian P. DeGenova
dated September 19, 2001.
(7) Exhibit 2--Copy of six-page Order of the State Board of
Pharmacy, Docket No. D-000809-004, in the matter of Joseph Neil Gioiello, R.Ph.
dated December 18, 2000.
(8) Exhibit 2A--Copy of four-page Statement of Joseph N. Gioiello
notarized July 5, 2000.
(9) Exhibit 3--Copy of five-page Dangerous Drug Distributor
Inspection Report of Troutman Drug Company dated July 6, 2000.
(10) Exhibit 4--Copy of twelve Accountability Statements for Audit
Review at Troutman Drug covering April 29, 1999 to July 5, 2000 for the following
drugs: Xanax 0.5mg, Alprazolam 0.5mg, Valium 5mg, Diazepam 5mg, Valium 10mg,
Diazepam 10mg, Vicodin 5/500, Lortab 5/500, Hydrocet 5/500, Hydrocodone
Bitartrate/APAP 5/500, Vicodin ES 7.5/750, and Hydrocodone Bitartrate 7.5/750.
(11) Exhibit 5--Copy of two Accountability
Statements for Audit Review at Troutman Drug covering April 29, 1999 to July 5,
2000 for Methylphenidate 10mg and Ritalin 10mg.
(12) Exhibit 6--Copy of seventeen Accountability Statements for Audit
Review at Troutman Drug covering April 29, 1999 to July 10, 2000 for the
following drugs: Percocet 10/650, Percocet 5/325, Roxicet 5/325, Tylox,
Roxilox, Dexedrine 5mg, Dexedrine Span. 5mg, Ritalin 5mg, Methylphenidate 5mg,
Ritalin 20mg, Methylphenidate 20mg, Ritalin ER 20mg, Methylphenidate ER 20mg,
OxyContin 10mg, OxyContin 20mg, OxyContin 40mg, and OxyContin 80mg.
(13) Exhibit 7--Copy of three-page Statement of Joseph Neil Gioiello
notarized October 3, 2000.
(14) Exhibit 8--Two-page copy of DEA Form 106, Report of Theft or Loss
of Controlled Substances, of Troutman Drug dated October 5, 2000.
(15) Exhibit 9--Copy of page one of the Ohio State Board of Pharmacy
Newsletter of May 2000, OH Vol. 21, No. 4; and copy of page three of DEA/NABP
Compliance News, not dated.
(16) Exhibit 10--Copy of five-page Indictment, State of Ohio vs.
Joseph Neil Gioiello, Case No. "Direct Presentment", Trumbull
County Common Pleas Court, May Fourth Term, 2001; Copy of six-page Finding on
Guilty Plea To Indictment, State of Ohio vs. Joseph N. Gioiello, Case
No. 01-CR-465, Trumbull County Common Pleas Court, dated August 13, 2001.
Respondent's
Exhibits:
(1) Exhibit A--Copy of page one of the Ohio State Board of Pharmacy
Newsletter of May, 2000, OH Vol. 21, No. 4; and copy of page three of DEA/NABP
Compliance News, not dated.
(2) Exhibit B--Copy of P.R.O., Inc. Pharmacist’s Recovery Contract
of Joe Gioiello dated January 28, 2001; Two-page letter from John J. Mallozzi,
B.S. Ed., CCDC-III-E, dated September 11, 2001; Two-page copy of Community
Solutions Association Discharge Summary And Continuing Care Plan of Joseph
Gioiello dated September 12, 2001.
(3) Exhibit C--Copy of thirty-nine pages of drug screen reports for
specimens collected from Joseph Gioiello on July 25, 2000, August 9, 2000,
August 25, 2000, September 13, 2000, September 25, 2000, October 12, 2000,
November 8, 2000, November 27, 2000, December 20, 2000, January 24, 2001,
February 10, 2001, March 8, 2001, April 5, 2001, April 27, 2001, May 21, 2001,
June 15, 2001, July 11, 2001, August 3, 2001, and August 30, 2001.
(4) Exhibit D--Twelve pages of support group attendance records
dated from July 9, 2000 to September 25, 2001.
(5) Exhibit E--Twelve pages of letters from the following: Dharl
Chintan CCDCIIIE, LSW dated August 27, 2001; David F. Merk dated September 9,
2001; Emil Dontenville, R.Ph. dated August 3, 2001; Robert F. Tschinkel dated
September 10, 2001; Robert J. Dougherty, R.Ph. dated August 4, 2001; Gwen
Mentzer, R.N., C.N.O.R., not dated; Edward L. Carson, Esq. dated September 6,
2001; Jeff (no last name given) dated August 28, 2001; Jeffrey A. Wallace,
R.Ph. and Elizabeth W. Wallace, R.Ph. dated September 10, 2001; and David A.
Pishotti, R.Ph. dated September 11, 2001.
(6) Exhibit F--Copy of four-page Motion For Drug Treatment in Lieu
of Conviction, State of Ohio vs. Joseph Neil Gioiello, Case No. 2001 CR
00465, Trumbull County Common Pleas Court, dated July 23, 2001; Copy of
three-page Entry Finding Defendant Eligible For Intervention In Lieu Of
Conviction, State of Ohio vs. Joseph Neil Gioiello, Case No. 01-CR-465,
Trumbull County Common Pleas Court, dated August 7, 2001; Copy of six-page
Finding on Guilty Plea To Indictment, State of Ohio vs. Joseph N. Gioiello,
Case No. 01-CR-465, Trumbull County Common Pleas Court, dated August 13, 2001;
Letter from James E. Tallman dated September 6, 2001; Copy of Trumbull County
Adult Probation Department Repayment Agreement for Joseph Gioiello, Docket No.
01-CR-456; Copy of Trumbull County Court of Common Pleas Probation Department
Rules of Supervision for Joseph Gioiello, Docket No. 01-CR-465, dated August
20, 2001; Copy of Trumbull County Common Pleas Adult Probation Receipt No.
19634 dated September 5, 2001; Copy of Trumbull County Common Pleas Court
Receipt No. 39991 dated September 5, 2001.
(7) Exhibit G--Two-page Summary of Pharmacy Continuing Education
Certificates; Thirty-four pages of copies of Continuing Pharmacy Education
Certificates dated from February 26, 1999 to May 12, 2001.
FINDING
OF FACT
After having heard the testimony, observed the
demeanor of the witnesses, considered the evidence, and weighed the credibility
of each, the State Board of Pharmacy finds Joseph Neil Gioiello has complied
with the terms set forth in the Order of the State Board of Pharmacy, Docket
No. D-000809-004, effective December 18, 2000.
ACTION
OF THE BOARD
On the basis of the Finding
of Fact set forth above, the State Board of Pharmacy hereby approves the
reinstatement of the pharmacist identification card, No. 03-1-17346, held by Joseph
Neil Gioiello to practice pharmacy in the state of Ohio and places Joseph Neil
Gioiello on probation for five years from the date the identification card is
issued, with the following conditions:
(A) Joseph Neil Gioiello must enter into a contract, signed within
thirty days after the effective date of this Order, with an Ohio Department of
Alcohol and Drug Addiction Services (ODADAS) treatment provider or a treatment
provider acceptable to the Board for a period of not less than five years and
submit a copy of the signed contract to the Board office with the renewal
application. The contract must provide
that:
(1) Random, observed urine drug screens shall be conducted each month
for the first twelve months and then at least once every three months for the
remaining four years.
(a) The urine sample must be given within twelve hours of notification. The urine drug screen must include testing
for creatinine or specific gravity of the sample as the dilutional standard.
(b) Results of all drug screens must be negative. Any positive results, including those which
may have resulted from ingestion of food, but excluding false positives which
resulted from medication legitimately prescribed, indicates a violation of the
contract and probation.
(2) The intervener/sponsor shall provide copies of all drug screen
reports to the Board in a timely fashion.
(3) Attendance is required a minimum of three times per week at an
Alcoholics Anonymous, Narcotics Anonymous, and/or similar support group
meeting.
(4) The program shall immediately report to the Board any
violations of the contract and/or lack of cooperation.
(B) Joseph Neil Gioiello must submit quarterly progress reports to
the Board (due January 10, April 10, July 10, and October 10 of each year of probation)
that include:
(1) The written report and documentation
provided by the treatment program pursuant to the contract, and
(2) A written description of Joseph Neil
Gioiello's progress towards recovery and what Mr. Gioiello has been doing
during the previous three months.
(C) Other terms of probation are as follows:
(1) The State Board of Pharmacy hereby declares that Joseph Neil
Gioiello's pharmacist identification card is not in good standing and thereby
denies the privilege of being a preceptor and training pharmacy interns
pursuant to paragraph (D)(1) of Rule 4729-3-01 of the Ohio Administrative Code.
(2) Joseph Neil Gioiello may not serve as a responsible pharmacist.
(3) Joseph Neil Gioiello may not destroy, assist in, or witness the
destruction of controlled substances.
(4) Joseph Neil Gioiello must abide by the contract from the
treatment provider and any violation must be reported to the Board immediately.
(5) Joseph Neil Gioiello must not violate the drug laws of the
State of Ohio, any other state, or the federal government.
(6) Joseph Neil Gioiello must abide by the rules of the State Board
of Pharmacy.
(7) Joseph Neil Gioiello must comply with the terms of this Order.
Joseph Neil Gioiello is hereby advised that the Board
may at any time revoke probation for cause, modify the conditions of probation,
and reduce or extend the period of probation.
At any time during this period of probation, the Board may revoke
probation for a violation occurring during the probation period.
THIS ORDER WAS
APPROVED BY A VOTE OF THE STATE BOARD OF PHARMACY.
MOTION CARRIED.
SO ORDERED.
The motion was seconded by Mrs. Teater and approved by the Board (Aye-7/Nay-0).
RES. 2002-046 Mr. Braylock then moved that the Board issue the following Order in the matter of David W. White, R.Ph.:
ORDER OF THE STATE BOARD OF
PHARMACY
(Docket No. D-010316-054)
In The Matter Of:
DAVID W. WHITE, R.Ph.
2424 Fairview #1
Cincinnati, Ohio 45219
(R.Ph. No. 03-1-20502)
INTRODUCTION
THE MATTER OF DAVID W. WHITE
CAME FOR HEARING ON OCTOBER 1, 2001, BEFORE THE FOLLOWING MEMBERS OF THE BOARD:
ANN D. ABELE, R.Ph. (presiding); GREGORY BRAYLOCK, R.Ph.; SUZANNE R. EASTMAN,
R.Ph.; ROBERT P. GIACALONE, R.Ph.; LAWRENCE J. KOST, R.Ph.; NATHAN S. LIPSYC,
R.Ph.; DOROTHY S. TEATER, PUBLIC MEMBER; AND JAMES E. TURNER, R.Ph.
DAVID W. WHITE WAS REPRESENTED BY HARRY PLOTNICK AND
THE STATE OF OHIO WAS REPRESENTED BY SALLY ANN STEUK, ASSISTANT ATTORNEY
GENERAL.
SUMMARY OF EVIDENCE
(A) Testimony
State's Witnesses:
(1) Michael Cluxton, Ohio State Board of Pharmacy
Respondent's Witnesses:
(1) David White, R.Ph., Respondent
(B) Exhibits
State's Exhibits:
(1) Exhibit 1--Copy of three-page Notice of Opportunity for Hearing
letter dated March 16, 2001.
(2) Exhibit 1A--Hearing Request letter from David White dated March
28, 2001.
(3) Exhibit 1B--Copy of Hearing Schedule letter dated April 9,
2001.
(4) Exhibit 1C--Copy of Hearing Schedule letter dated May 17, 2001.
(5) Exhibit 1D--Copy of Ohio Pharmacist Computer Record of David
Wayne White, dated April 6, 2001.
(6) Exhibit 1E--Notice of Representation and Appearance letter from
Harry B. Plotnick dated September 17, 2001.
(7) Exhibit 2--Statement of David W. White notarized January 10,
2001.
(8) Exhibit 2A--CVS/Revco #6126 Pharmacist’s Statement re David
White covering January 1, 2000 through January 30, 2001 dated January 30, 2001.
(9) Exhibit 3--Prescription No. 6735041 dated October 19, 2000, and
handwritten note; Copy of Kroger Pharmacy Log Sheet, Store #327 for
prescriptions dated October 7, 2000 to October 21, 2000.
(10) Exhibit 4--Statement of James B. Raasch, Jr., R.Ph. notarized
January 24, 2001.
(11) Exhibit 5--Copy of Prosecuting Attorney's Request For Issuance of
Warrant Upon Indictment and two-page Indictment, State of Ohio vs. David
White, Case No. B0100337, Hamilton County Common Pleas Court, dated January
23, 2001.
(12) Exhibit 6--Two-page copy of Entry Withdrawing Plea of Not Guilty
And Entering Plea of Guilty, State of Ohio vs. David White, Case No.
B0100337, Hamilton County Common Pleas Court,
dated March 13, 2001.
(13) Exhibit 7--Copy of Drug Court Judgement Entry Intervention In
Lieu of Conviction, State of Ohio vs. David White, Case No. B0100337,
Hamilton County Common Pleas Court, dated March 29, 2001.
Respondent's Exhibits:
(1) Exhibit A--Copy of letter from Harris Cohen, MSW, LSW, RC dated
September 14, 2001.
(2) Exhibit B--Copy of letter from Gregory L. Isaac, M.D. dated
September 6, 2001.
(3) Exhibit C--Copy of letter from Chris O. Costas, M.D. dated
September 12, 2001.
FINDINGS
OF FACT
After having heard the
testimony, observed the demeanor of the witnesses, considered the evidence, and
weighed the credibility of each, the State Board of Pharmacy finds the
following to be fact:
(1) Records of the State Board of Pharmacy indicate that David
Wayne White was originally licensed by the State of Ohio on November 2, 1994,
pursuant to examination, and is currently licensed to practice pharmacy in the
state of Ohio.
(2) David W. White did, on or about October, 2000, intentionally
create and/or knowingly possess a false or forged prescription, to wit: David
W. White set up a false patient profile and created a false prescription for
100 doses of Ultram 50mg, with refills, while practicing pharmacy at K-mart in
Cudahy, Wisconsin. Such conduct is in
violation of Section 2925.23(B) of the Ohio Revised Code.
(3) David W. White did, on or about October 19, 2000, by deception,
procure the dispensing of a dangerous drug, to wit: after creating a false
prescription and patient profile in a pharmacy in Wisconsin where David W.
White had been employed as a pharmacist, and after moving to Ohio, David W.
White obtained a transfer of the false prescription to an Ohio pharmacy and
David W. White obtained 100 doses of Ultram 50mg by pretending to be a
legitimate patient. Such conduct is in
violation of Section 2925.22 of the Ohio Revised Code.
(4) David W. White did, on or about January 2, 2001, by deception,
procure the dispensing of a dangerous drug, to wit: after creating a false
prescription and patient profile in a pharmacy in Wisconsin where David W.
White had been employed as a pharmacist, and after moving to Ohio, David W.
White obtained a transfer of the false prescription to an Ohio pharmacy. David W. White had obtained the first
dispensing of 100 doses of Ultram 50mg by pretending to be a legitimate
patient; on January 2, 2001, David W. White obtained a refill of the drug by
telephoning the pharmacy and again posing as the fictitious patient. Such conduct is in violation of Section
2925.22 of the Ohio Revised Code.
CONCLUSIONS
OF LAW
(1) Upon consideration of the record as a whole, the State Board of
Pharmacy concludes that paragraphs (2) through (4) of the Findings of Fact
constitute being guilty of a felony and gross immorality as provided in
Division (A)(1) of Section 4729.16 of the Ohio Revised Code.
(2) Upon consideration of the record as a whole, the State Board of
Pharmacy concludes that paragraphs (2) through (4) of the Findings of Fact
constitute being guilty of dishonesty and unprofessional conduct in the
practice of pharmacy as provided in Division (A)(2) of Section 4729.16 of the
Ohio Revised Code.
(3) Upon consideration of the record as a whole, the State Board of
Pharmacy concludes that paragraphs (2) through (4) of the Findings of Fact
constitute abusing drugs or being impaired physically or mentally to such a
degree as to render him unfit to practice pharmacy as provided in Division
(A)(3) of Section 4729.16 of the Ohio Revised Code.
(4) Upon consideration of the record as a whole, the State Board of
Pharmacy concludes that paragraphs (2) through (4) of the Findings of Fact
constitute being guilty of willfully violating, conspiring to violate,
attempting to violate, or aiding and abetting the violation of provisions of
Chapter 2925. of the Revised Code as provided in Division (A)(5) of Section
4729.16 of the Ohio Revised Code.
ACTION
OF THE BOARD
Pursuant
to Section 4729.16 of the Ohio Revised Code, and on the basis of the Findings
of Fact and Conclusions of Law, the State Board of Pharmacy hereby suspends
indefinitely the pharmacist identification card, No. 03-1-20502, held by David
W. White and such suspension is effective as of the date of the mailing of this
Order.
(A) David W. White, pursuant to Rule 4729-9-01(F) of the Ohio
Administrative Code, may not be employed by or work in a facility licensed by
the State Board of Pharmacy to possess or distribute dangerous drugs during
such period of suspension.
(B) David W. White, pursuant to Section 4729.16(B) of the Ohio
Revised Code, must return the identification card and license (wall
certificate) to the office of the State Board of Pharmacy within ten days after
receipt of this Order unless the Board office is already in possession of
both. The identification card and wall
certificate should be sent by certified mail, return receipt requested.
Further, after one year from the effective date of
this Order, the Board will consider any petition filed by David W. White for a
hearing, pursuant to Ohio Revised Code Chapter 119., for reinstatement. The Board will only consider reinstatement
of the license to practice pharmacy in Ohio if the following conditions have
been met:
(A) David
W. White must obtain, within sixty days after the effective date of this Order,
a full psychiatric or psychological evaluation by a licensed psychiatrist or
psychologist and must abide by the treatment plan as designed by that
psychiatrist or psychologist. The
psychiatrist or psychologist must provide an initial status report, which
includes the recommended treatment plan, to the Board within ten days after
completing the assessment.
(B) David W. White must enter into a contract,
signed within thirty days after the effective date of this Order, with an Ohio
Department of Alcohol and Drug Addiction Services (ODADAS) treatment provider
or a treatment provider acceptable to the Board for a period of not less than
five years and, upon signing, mail a copy of the contract to the Board
office. The contract must provide that:
(1) Random, observed
urine drug screens shall be conducted at least once each month.
(a) The urine sample must be given within twelve hours of notification. The urine drug screen must include testing
for creatinine or specific gravity of the sample as the dilutional standard.
(b) Tramadol must be added to the standard urine drug screen.
(c) Results of all drug screens must be negative. Any positive results, including those which
may have resulted from ingestion of food, but excluding false positives which
resulted from medication legitimately prescribed, indicates a violation of the
contract.
(2) Attendance
is required a minimum of three times per week at an Alcoholics Anonymous,
Narcotics Anonymous, and/or similar support group meeting.
(3) The
program shall immediately report to the Board any violations of the contract
and/or lack of cooperation.
(C) David W. White must demonstrate
satisfactory proof to the Board that he is no longer abusing drugs or impaired
physically or mentally to such a degree as to render him unfit to practice
pharmacy.
(D) David W. White must provide, at the reinstatement
petition hearing, documentation of the following:
(1) Compliance with the licensed psychiatrist's or psychologist's
recommended treatment plan;
(2) A report by the licensed psychiatrist or psychologist regarding
David W. White's fitness for readmission into the practice of pharmacy;
(3) Compliance with the contract required above (e.g.-proof of
giving the urine sample within twelve hours of notification and copies of all
drug urine screen reports, meeting attendance records, treatment program
reports, etc.);
(4) Compliance with the continuing pharmacy education requirements
set forth in Chapter 4729-7 of the Ohio Administrative Code as applicable and
in effect on the date of petitioning the Board for reinstatement;
(5) Compliance with the terms of this Order.
(D) If reinstatement is not accomplished within
three years of the effective date of this Order, David W. White must show
successful completion of the NAPLEX examination or an equivalent examination
approved by the Board.
THIS ORDER WAS
APPROVED BY A VOTE OF THE STATE BOARD OF PHARMACY.
MOTION CARRIED.
SO ORDERED.
The motion was seconded by Mr. Turner and approved by the Board (Aye-7/Nay-0).
5:24 p.m.
The meeting was recessed until Tuesday, October 2, 2001.
tuesday, october 2, 2001
8:00 a.m. ROLL CALL
The State Board of Pharmacy reconvened in Room 1919, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio with the following members present:
Ann D. Abele, R.Ph. (President); Diane C. Adelman, R.Ph. (Vice-President); Gregory Braylock, R.Ph.; Suzanne R. Eastman, R.Ph.; Robert P. Giacalone, R.Ph.; Lawrence J. Kost, R.Ph.; Nathan S. Lipsyc, R.Ph.; Dorothy S. Teater, Public Member; and James E. Turner, R.Ph.
The Board was joined by Doug Darbro, M.D. of Health Probe to present Health Probe electronic prescription transmission system.
9:00 a.m.
The presentation ended and the Board took a brief recess.
9:13 a.m.
The Board was joined by Assistant Attorney General Sally Ann Steuk for the purpose of conducting an adjudication hearing in accordance with Ohio Revised Code Chapters 119. and 4729. in the matter of Michael S. Gladieux, R.Ph., Perrysburg.
10:28 a.m.
The hearing ended and the record was closed. The Board took a brief recess.
10:47 a.m.
The Board was joined by Assistant Attorney General Sally Ann Steuk for the purpose of conducting an adjudication hearing in accordance with Ohio Revised Code Chapters 119. and 4729. in the matter of Debra Lynn Cooper, R.Ph., Uhrichsville.
11:56 a.m.
The hearing ended and the record was closed. The Board recessed for lunch.
1:00 p.m.
The Board reconvened in Room 1930, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio, for the purpose of meeting with the candidates for licensure by reciprocity with the following members present:
Ann D. Abele, R.Ph. (President); Diane C. Adelman, R.Ph. (Vice-President); Gregory Braylock, R.Ph.; Suzanne R. Eastman, R.Ph.; Robert P. Giacalone, R.Ph.; Lawrence J. Kost, R.Ph.; Nathan S. Lipsyc, R.Ph.; Dorothy S. Teater, Public Member; and James E. Turner, R.Ph.
RES. 2002-047 Following presentations by Board members and self-introductions by the candidates for licensure by reciprocity, Mrs. Adelman moved that the Board approve the following candidates for licensure. The motion was seconded by Ms. Eastman and approved by the Board (Aye-8/Nay-0).
JENNIFER
MARGARET ANDERSON |
|
PENNSYLVANIA |
RACHEL
FOGERTY |
|
NEW
YORK |
JAMES
DANIEL GALLAGHER |
|
MICHIGAN |
JOSHANA
KARKI |
|
MICHIGAN |
KENDRA
DIANE KRESS |
|
NEW
YORK |
DANA
COOPER MILLER |
|
KENTUCKY |
KURT
RICHARD NESTEL, JR. |
|
PENNSYLVANIA |
ROSANE
OLYHA |
|
NEW
YORK |
BERNADETTE
JEAN WEITZ |
|
MASSACHUSETTS |
1:30 p.m.
The Board reconvened in Room 1919 with all members present to continue the hearing in the matter of James W. Smetana, R.Ph., West Milton, that had been continued from the September 11, 2001 meeting when the building was closed by order of the Governor. President Abele announced that Ms. Eastman would not participate in this hearing nor would she participate in the adjudication since she was not present during the initial part of the hearing held on September 11, 2001.
3:34 p.m.
The hearing ended and the record was closed. The Board took a brief recess.
3:51 p.m.
The Board was joined by Assistant Attorney General Sally Ann Steuk for the purpose of conducting an adjudication hearing in accordance with Ohio Revised Code Chapters 119. and 4729. in the matter of Dennis J. Farina, R.Ph., Ashtabula.
5:13 p.m.
The hearing ended and the record was closed. The Board took a brief recess.
5:20 p.m.
The Board was joined by Assistant Attorney General Sally Ann Steuk for the purpose of presenting for adjudication, in accordance with Ohio Revised Code Chapters 119. and 4729., the matters of CVS/pharmacy #3484, Columbus and Ojinika I. Mora, R.Ph., Columbus.
5:46 p.m.
The presentation concluded and the record was closed.
5:50 p.m.
The meeting was recessed until Wednesday, October 3, 2001.
wednesday, October 3, 2001
8:00 a.m. ROLL CALL
The State Board of Pharmacy reconvened in Room 1919, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio with the following members present:
Ann D. Abele, R.Ph. (President); Diane C. Adelman, R.Ph. (Vice-President); Gregory Braylock, R.Ph.; Suzanne R. Eastman, R.Ph.; Robert P. Giacalone, R.Ph.; Lawrence J. Kost, R.Ph.; Nathan S. Lipsyc, R.Ph.; Dorothy S. Teater, Public Member; and James E. Turner, R.Ph.
8:04 a.m.
Ms. Eastman moved that the Board go into Executive Session for the purpose of the investigation of complaints regarding licensees and registrants pursuant to Section 121.22(G)(1) of the Revised Code. The motion was seconded by Mr. Kost and a roll call vote was conducted by President Abele as follows: Adelman-Yes, Braylock-Yes, Eastman-Yes, Giacalone-Yes, Lipsyc-Yes, Kost-Yes, Teater-Yes, and Turner-Yes.
8:50 a.m.
RES. 2002-048 The Executive Session ended and the meeting was opened to the public. Mr. Turner moved that the Board issue the following Order in the matter of Michael S. Gladieux, R.Ph.:
ORDER OF THE STATE BOARD OF PHARMACY
(Docket
No. D-010713-004)
In
The Matter Of:
MICHAEL SCOTT GLADIEUX, R.Ph.
7195
Winding Brook Road
Perrysburg,
Ohio 43551
(R.Ph. No. 03-1-19036)
INTRODUCTION
THE MATTER OF MICHAEL SCOTT GLADIEUX CAME FOR
HEARING ON OCTOBER 2, 2001, BEFORE THE FOLLOWING MEMBERS OF THE BOARD: ANN D. ABELE,
R.Ph. (presiding); DIANE C. ADELMAN, R.Ph.; GREGORY BRAYLOCK, R.Ph.; SUZANNE R.
EASTMAN, R.Ph.; ROBERT P. GIACALONE, R.Ph.; LAWRENCE J. KOST, R.Ph.; NATHAN S.
LIPSYC, R.Ph.; DOROTHY S. TEATER, PUBLIC MEMBER; AND JAMES E. TURNER, R.Ph.
MICHAEL SCOTT GLADIEUX WAS NOT REPRESENTED BY
COUNSEL AND THE STATE OF OHIO WAS REPRESENTED BY SALLY ANN STEUK, ASSISTANT
ATTORNEY GENERAL.
SUMMARY
OF EVIDENCE
(A) Testimony
State's Witnesses:
(1) None
Respondent's Witnesses:
(1) Michael Quigley
(2) Michael Scott Gladieux, R.Ph., Respondent
(B) Exhibits
State's Exhibits:
(1) Exhibit 1--Hearing Request letter from Michael S. Gladieux
dated July 5, 2001.
(2) Exhibit 1A--Copy of Hearing Schedule letter dated June 12,
2001.
(3) Exhibit 1B--Copy of Hearing Schedule letter dated July 13,
2001.
(4) Exhibit 1C--Copy of Hearing Schedule letter dated July 27,
2001.
(5) Exhibit 1D--Copy of Ohio Pharmacist Computer Record of Michael
Scott Gladieux.
(6) Exhibit 2--Copy of eight-page Order of the State Board of Pharmacy,
Docket No. D-000307-049 in the matter of Michael Scott Gladieux, R.Ph. dated
October 6, 2000.
(7) Exhibit 3--Copy of Meijer Pharmacy #156 Accountability
Statement for Hydrocodone/APAP 5/500mg tablets dated February 14, 2000.
(8) Exhibit 4--Copy of Meijer Pharmacy #156 Accountability
Statement for Hydrocodone/APAP 7.5/750mg tablets dated February 14, 2000.
(9) Exhibit 5--Copy of Meijer Pharmacy #156 Accountability
Statement for Hydrocodone/APAP 10/500mg tablets dated February 14, 2000.
(10) Exhibit 6--Copy of Meijer Pharmacy #156 Accountability Statement
for Hydrocodone/APAP 10/650mg tablets dated February 14, 2000.
(11) Exhibit 7--Copy of Meijer Pharmacy #156 Accountability Statement
for Vicodin ES tablets dated February
14, 2000.
(12) Exhibit 8--Copy of Meijer Pharmacy #156 Accountability Statement
for Vicodin HP tablets dated February
14, 2000.
(13) Exhibit 9--Ohio State Board of Pharmacy Drug Audit Accountability
Sheet of CVS/pharmacy #4434 for Norco Tabs dated February 29, 2000.
(14) Exhibit 10--Copy of Meijer Store 115 Schedule Drug Worksheet
covering May 20, 1999 to February 24, 2000.
(15) Exhibit 11--Copy of Meijer Store 118 Schedule Drug Worksheet
covering May 7, 1999 to February 24, 2000.
(16) Exhibit 12--Copy of Meijer Store 117 Schedule Drug Worksheet
covering May 18, 1999 to February 24, 2000.
(17) Exhibit 13--Copy of Meijer Store 116 Schedule Drug Worksheet
covering May 14, 1999 to February 24, 2000.
(18) Exhibit 14--Copy of five-page Judgment Entry/Arraignment and Plea
Order on Motion in Treatment in Lieu of Conviction, State of Ohio vs.
Michael Gladiuex,(sic) Case No. 00CR066, Wood County Common Pleas
Court dated March 27, 2000.
(19) Exhibit 15--Copy of Order, State of Ohio v. Michael Gladeiux,(sic)
Case No. G-4801-CR-0200001708, Lucas County Common Pleas Court dated August 23,
2000.
(20) Exhibit 16--Copy of Bowling Green Police Division Written
Statement Requesting Release of Records To Wood County Hospital re Michael S.
Gladieux dated February 11, 2000/Response Form from Linda Cox dated February
16, 2000; Copy of two-page Wood County Hospital urine drug screen report of
Michael S. Gladieux dated February 13, 2000.
Respondent's Exhibits:
(1) Exhibit A1--Letter from Ginny Gladieux,
not dated.
(2) Exhibit A2--Letter from Jody C. Storer
dated September 21, 2001.
(3) Exhibit A3--Letter from Gary F. Gladieux, M.D. dated September
26, 2001.
(4) Exhibit A4--Two-page letter from William F. Hayes dated
September 25, 2001.
(5) Exhibit A5--Letter from Dolores Gladieux, not dated.
(6) Exhibit A6--Letter from Ann M. Garcia dated September 13, 2001.
(7) Exhibit A7--Letter from Ann Garcia dated September 25, 2001.
(8) Exhibit A8--Letter from W. B. (Bill) Kunkle, BA, BS, BS, CCDC
II dated September 24, 2001.
(9) Exhibit A9--Letter from Freddie Jordan, M.Ed., LPC, Clinical
Therapist dated September 26, 2001.
(10) Exhibit A10-A12--Pages 6, 7, and 8 of the Order of the State
Board of Pharmacy in the matter of Michael Scott Gladieux, R.Ph. dated October
6, 2000.
(11) Exhibit A13-A14--Two-page PRO Inc. Pharmacist’s Recovery Contract
of Michael Gladieux dated January 7, 2001.
(12) Exhibit A15-A29--Eighteen pages of Continuing Pharmacy Education Certificates dated from August 1,
1997 to July 10, 2001.
(13) Exhibit A30-A36--Copy of nine pages of Quest Diagnostics drug
screen reports for samples collected from Michael Gladieux on February 10,
2001, March 10, 2001, April 29, 2001, May 21, 2001, June 25, 2001, July 30,
2001, August 15, 2001, and September 17, 2001.
(14) Exhibit A37-A55--Two hundred three slips of support group
attendance records dated from March 4, 2000 to September 10, 2001.
FINDING
OF FACT
After having heard the testimony, observed the
demeanor of the witnesses, considered the evidence, and weighed the credibility
of each, the State Board of Pharmacy finds that Michael Scott Gladieux has not
complied with the terms set forth in the Order of the State Board of Pharmacy,
Docket No. D-000307-049, effective October 6, 2000, nor has he demonstrated
satisfactory proof to the Board that he is no longer addicted to or abusing
liquor or drugs or impaired physically or mentally to such a degree as to
render him unfit to practice pharmacy.
ACTION
OF THE BOARD
On the basis of the Findings of Fact set forth
above, the State Board of Pharmacy hereby denies the reinstatement petition of
Michael Scott Gladieux. Pursuant to
Rule 4729-9-01(F) of the Ohio Administrative Code, Michael Scott Gladieux may
not be employed by or work in a facility licensed by the State Board of
Pharmacy to possess or distribute dangerous drugs during suspension.
Further, at the Board's May 2002 meeting or
thereafter, the Board will consider any petition presented by Michael Scott
Gladieux, pursuant to Ohio Revised Code Chapter 119., for reinstatement. The Board will only consider reinstatement
of the license to practice pharmacy in Ohio if Michael Scott Gladieux provides
documentation of continuous compliance with the Board's October 6, 2000 Order
and demonstrates satisfactory proof that he is no longer addicted to or abusing
liquor or drugs or impaired physically or mentally to such a degree as to
render him unfit to practice pharmacy.
THIS ORDER WAS
APPROVED BY A VOTE OF THE STATE BOARD OF PHARMACY.
MOTION CARRIED.
SO ORDERED.
The motion was seconded by Mr. Kost and approved by the Board (Aye-7/Nay-1).
RES. 2002-049 Mr. Braylock then moved that the Board issue the following Order in the matter of Debra Lynn Cooper R.Ph.:
ORDER OF THE STATE BOARD OF PHARMACY
(Docket
No. D-001003-012)
In
The Matter Of:
DEBRA LYNN COOPER, R.Ph.
61
West Main Street
Lexington,
Ohio 44904
(R.Ph. No. 03-3-21795)
INTRODUCTION
THE MATTER OF DEBRA LYNN COOPER CAME FOR HEARING ON
OCTOBER 2, 2001, BEFORE THE FOLLOWING MEMBERS OF THE BOARD: ANN D. ABELE, R.Ph.
(presiding); DIANE C. ADELMAN, R.Ph.; GREGORY BRAYLOCK, R.Ph.; SUZANNE R.
EASTMAN, R.Ph.; ROBERT P. GIACALONE, R.Ph.; LAWRENCE J. KOST, R.Ph.; NATHAN S.
LIPSYC, R.Ph.; DOROTHY S. TEATER, PUBLIC MEMBER; AND JAMES E. TURNER, R.Ph.
DEBRA LYNN COOPER WAS REPRESENTED BY DAVID W. GRAUER
AND THE STATE OF OHIO WAS REPRESENTED BY SALLY ANN STEUK, ASSISTANT ATTORNEY
GENERAL.
SUMMARY
OF EVIDENCE
(A) Testimony
State's Witnesses:
(1) David G. Gallagher, Ohio State Board of Pharmacy
Respondent's Witnesses:
(1) Debra Lynn Cooper, Respondent
(2) Thomas Foti, R.Ph.
(3) Ellen Laubis
(B) Exhibits
State's Exhibits:
(1) Exhibit 1--Copy of four-page Summary Suspension Order/Notice of
Opportunity for Hearing letter dated October 3, 2000.
(2) Exhibit 1A--Hearing Request letter from David W. Grauer dated
November 7, 2000.
(3) Exhibit 1B--Copy of letter from David L.
Rowland dated November 7, 2000.
(4) Exhibit 1C--Notice of Appearance letter and Certificate of
Service from David W. Grauer dated November 20, 2000.
(5) Exhibit 1D--Request for Hearing letter and Certificate of
Service from David W. Grauer dated November 20, 2000.
(6) Exhibit 1E--Copy of two-page Hearing Schedule letter dated
November 21, 2000.
(7) Exhibit 1F--Request for Continuance letter from David W. Grauer
dated March 20, 2001.
(8) Exhibit 1G--Copy of Hearing Schedule letter dated March 21,
2001.
(9) Exhibit 1H--Copy of Hearing Schedule letter dated July 23,
2001.
(10) Exhibit 1I--Copy of Ohio Board of Pharmacy pharmacist computer
record of Debra Lynn Cooper.
(11) Exhibit 1J--Copy of Hearing Schedule letter dated August 24,
2001.
(12) Exhibit 1K--Motion for Continuance letter
and Certificate of Service from David W. Grauer dated August 28, 2001.
(13) Exhibit 2--Rite Aid Prescription No. 02411
105238 dated August 10, 2000.
(14) Exhibit 3--Rite Aid Prescription No. 02411 106127 dated September
2, 2000.
(15) Exhibit 4--Four-page Statement of Debra Cooper notarized
September 27, 2000.
(16) Exhibit 5--Copy of three-page Pharmacy Profile report re Debra
Cooper dated April 20, 2000, and copy of letter from Carol S. Harris dated
April 21, 2000.
(17) Exhibit 6--Copy of Rite Aid-N. Tuscarawas Village Plaza Customer
History Report covering January 1, 1997 to September 27, 2000, re Debra L.
Cooper dated September 27, 2000.
(18) Exhibit 7--Copy of Medicine Shoppe Insurance Profile printout
covering September 28, 1999 to September 28, 2000, re Debra L. Cooper dated
September 28, 2000.
(19) Exhibit 8--Copy of RAP - S. Main Street Customer History Report
covering January 1, 1999 to December 31, 1999, re Debra Cooper dated April 24,
2000.
(20) Exhibit 9--Copy of six-page CVS/Revco #3457 Pharmacist’s
Statement covering January 1, 1999 to April 24, 2000, re Debra Cooper dated April 24, 2000.
(21) Exhibit 10--Copy of Drug Castle #8 Controlled Substance Audit
Report (By Drug) re Stadol NS 10mg/ml spray dated April 25, 2000.
(22) Exhibit 11--Copy of two-page Drug Castle #9
Medical Expenses report covering January 1, 1999 to April 20, 2000, re Debra
Cooper, not dated; copy of Drug Castle No. 9 Controlled .Substance Audit Report
By Drug) re Stadol NS 10mg/ml spray, not dated.
(23) Exhibit 12--Copy of Drug Castle #10 Controlled Substance Audit
Report (By Drug) re Stadol NS 10mg/ml spray, not dated.
(24) Exhibit 13--Copy of Rite Aid N.-Tuscarawas Village Plaza Customer
History Report covering January 1, 1997 to September 27, 2000 re Aaron B.
Cooper dated September 27, 2000.
(25) Exhibit 14--Letter from Daniel H. Brumfield, M.D. dated September
26, 2000.
(26) Exhibit 15--Two-page copy of Report of Theft or Loss of
Controlled Substances of Drug Castle, not dated.
(27) Exhibit 16--Copy of three-page Indictment, State of Ohio vs.
Debra L. Cooper, Case No. 2001CR050135, Tuscarawas County Court of Common
Pleas, dated May 14, 2001.
Respondent's Exhibits:
(1) Exhibit A--Copy of nine pages of AA/NA attendance verification
records dated from December 15, 2000 to September 24, 2001.
(2) Exhibit B--Copy of ten Quest
Diagnostics Chain of Custody Document/Request Forms of Debra Cooper for
specimens collected on February 1, 2001, February 23, 2001, March 19, 2001,
April 17, 2001, May 17, 2001, June 14, 2001, July 2, 2001, July 27, 2001,
August 23, 2001, and September 13, 2001.
(3) Exhibit C--Copy of ten Quest Diagnostics drug screen reports
for specimens collected from Debra Cooper on February 1, 2001, February 23,
2001, March 19, 2001, April 17, 2001, May 13, 2001, June 14, 2001, July 2,
2001, July 27, 2001, August 23, 2001, and September 13, 2001.
(4) Exhibit D--Copy of Shepherd Hill Hospital Recovery Plan of
Debra Cooper dated December 15, 2000; copy of letter from Frederick N. Karaffa,
M.D. dated March 7, 2001; copy of letter from Frederick N. Karaffa, M.D. dated
September 11, 2001; copy of letter from Ellen Laubis, M.Ed., CCDC III dated
March 14, 2001; copy of letter from Ellen Laubis, M.Ed., CCDC III dated August
7, 2001.
(5) Exhibit E--Copy of two-page Pharmacist’s Recovery Contract of
Debra L. Cooper dated January 5, 2001.
(6) Exhibit F--Seventeen pages of copies of letters from the
following: Christopher Hart, R.Ph.
dated August 7, 2001; Thomas W. Foti, R.Ph., not dated; Judy Nign dated March
10, 2001; Perry Nign, not dated; Lois P. Thompson dated March 10, 2001; Leslie
Booth, not dated; Jennifer, Ashten, and Bristen Nign dated March 11, 2001;
Vickie Graves dated August 5, 2001; Reverend Gordon Myers dated March 11, 2001;
Andrew C. Basinger, D.D.S. dated March 6, 2001; Cheryl Nalle dated August 6,
2001; John I. Anderson Jr., not dated; Brooke Love dated March 8, 2001; and
Susan L. Davis dated March 14, 2001.
(7) Exhibit G--Six pages of copies of
Continuing Pharmacy Education Certificates dated April 29, 2001, July 29, 2001,
September 3, 2001, September 4, 2001, and September 5, 2001.
(8) Exhibit H--Two-page copy of Conditions of Supervision for Debra
Cooper dated September 19, 2001; Copy of Parole Officer Laurie Stewart’s
calling card; Copy of four-page Judgement Entry, State of Ohio vs. Debra L.
Cooper, Case No. 2001 CR 05 0135, Tuscarawas County Common Pleas Court,
dated September 26, 2001.
FINDINGS
OF FACT
After having heard the testimony, observed the
demeanor of the witnesses, considered the evidence, and weighed the credibility
of each, the State Board of Pharmacy finds the following to be fact:
(1) Records
of the State Board of Pharmacy indicate that Debra Lynn Cooper was originally
licensed by the State of Ohio on February 27, 1997, pursuant to examination,
and that her license to practice pharmacy in the state of Ohio was summarily
suspended effective October 3, 2000.
(2) Debra Lynn Cooper is addicted to liquor or drugs or impaired
physically or mentally to such a degree as to render her unfit to practice pharmacy,
to wit: Debra Lynn Cooper is admittedly addicted to Stadol, a Schedule IV
controlled substance; Debra Lynn Cooper became addicted after having used
Stadol to treat migraine headaches; Debra Lynn Cooper practiced pharmacy while
being impaired; and, Debra Lynn Cooper forged prescriptions to cover her
thefts. Such conduct indicates that
Debra Lynn Cooper falls within the ambit of Sections 3719.121(A), 3719.121(B),
and 4729.16(A)(3) of the Ohio Revised Code.
(3) Debra Lynn Cooper did, on or about the following dates,
intentionally create and/or knowingly possess false or forged prescriptions, to
wit: Debra Lynn Cooper created the following prescriptions in order to obtain
the controlled substance Stadol:
Rx# |
|
Date
|
105238T |
|
08/10/00 |
106127 |
|
09/02/00 |
Such conduct is in violation
of Section 2925.23(B)(1) of the Ohio Revised Code.
(4) Debra Lynn Cooper did, from January 1, 1999, through April 15,
2000, by deception, procure a prescription for a dangerous drug, to wit: Debra Lynn
Cooper obtained 60 bottles of Stadol, a Schedule IV controlled substance,
without prescriptions for a legitimate medical purpose from several different
pharmacies. Such conduct is in
violation of Section 2925.22(A) of the Ohio Revised Code.
(5) Debra Lynn Cooper did, from September 7, 1999, through April 6,
2000, with purpose to deprive, knowingly obtain or exert control over dangerous
drugs, the property of Drug Castle Pharmacy, 6550 Brandt Pike, Huber Heights,
Ohio, beyond the express or implied consent of the owner, to wit: Debra Lynn
Cooper stole ten bottles of Stadol NS, a Schedule IV controlled substance,
valued at $650.00 from her employer.
Such conduct is in violation of Section 2913.02 of the Ohio Revised
Code.
(6) Debra Lynn Cooper did, on or about September 25, 2000, by
deception, procure a prescription for a dangerous drug, to wit: Debra Lynn
Cooper obtained a prescription for Promethazine & Codeine Syrup, a Schedule
III controlled substance, from her physician.
Debra Lynn Cooper failed to advise her physician of her addiction and
continued use of Stadol. Such conduct
is in violation of Section 2925.22(A) of the Ohio Revised Code.
(7) Debra Lynn Cooper, R.Ph. did, on or about September 27, 2000,
possess dangerous drugs when not in accordance with Chapters 4729. and 4731. of
the Ohio Revised Code, to wit: Debra Lynn Cooper possessed twelve and one-half
units of Cyclobenzaprine Hydrochloride 10mg and one unit of Furosemide 40mg
without having a prescription for a legitimate medical purpose. Such conduct is in violation of Section
4729.51(C)(3) of the Ohio Revised Code.
CONCLUSIONS
OF LAW
(1) Upon
consideration of the record as a whole, the State Board of Pharmacy concludes that
paragraphs (3) through (7) of the Findings of Fact constitute being guilty of a
felony and gross immorality as provided in Division (A)(1) of Section 4729.16
of the Ohio Revised Code.
(2) Upon
consideration of the record as a whole, the State Board of Pharmacy concludes
that paragraphs (3) through (7) of the Findings of Fact constitute being guilty
of dishonesty and unprofessional conduct in the practice of pharmacy as
provided in Division (A)(2) of Section 4729.16 of the Ohio Revised Code.
(3) Upon consideration of the record as a whole, the State Board of
Pharmacy concludes that paragraph (2) of the Findings of Fact constitutes
being addicted to or abusing liquor or drugs or impaired physically or mentally
to such a degree as to render her unfit to practice pharmacy as provided in
Division (A)(3) of Section 4729.16 of the Ohio Revised Code.
(4) Upon consideration of the record as a whole, the State Board of
Pharmacy concludes that paragraphs (3), (4), (6), and (7) of the Findings of
Fact constitute being guilty of willfully violating, conspiring to violate,
attempting to violate, or aiding and abetting the violation of provisions of
Chapter 2925. or 4729. of the Revised Code as provided in Division (A)(5) of
Section 4729.16 of the Ohio Revised Code.
ACTION
OF THE BOARD
Pursuant to Section 3719.121 of the Ohio Revised
Code, the State Board of Pharmacy hereby removes the Summary Suspension Order
issued to Debra Lynn Cooper on October 3, 2000.
Pursuant to Section 4729.16 of the Ohio Revised
Code, and on the basis of the Findings
of Fact and Conclusions of Law set forth above, the State Board of Pharmacy
hereby suspends indefinitely the pharmacist identification card, No.
03-3-21795, held by Debra Lynn Cooper and such suspension is effective as of the
date of the mailing of this Order.
(A) Debra Lynn Cooper, pursuant to Rule 4729-9-01(F) of the Ohio
Administrative Code, may not be employed by or work in a facility licensed by
the State Board of Pharmacy to possess or distribute dangerous drugs during
such period of suspension.
(B) Debra Lynn Cooper, pursuant to Section 4729.16(B) of the Ohio
Revised Code, must return the identification card and license (wall
certificate) to the office of the State Board of Pharmacy within ten days after
receipt of this Order unless the Board office is already in possession of
both. The identification card and wall
certificate should be sent by certified mail, return receipt requested.
Further, after six months from the effective date of
this Order, the Board will consider any petition filed by Debra Lynn Cooper for
a hearing, pursuant to Ohio Revised Code Chapter 119., for reinstatement. The Board will only consider reinstatement
of the license to practice pharmacy in Ohio if the following conditions have
been met:
(A) Debra Lynn Cooper must enter into a
contract, signed within thirty days after the effective date of this Order,
with an Ohio Department of Alcohol and Drug Addiction Services (ODADAS)
treatment provider or a treatment provider acceptable to the Board for a period
of not less than five years and, upon signing, mail a copy of the contract to
the Board office. The contract must
provide that:
(1) Random, observed urine drug screens shall be conducted at least once
each month.
(a) The urine sample must be given within twelve hours of notification. The urine drug screen must include testing
for creatinine or specific gravity of the sample as the dilutional standard.
(b) Results of all drug screens must be negative. Any positive results, including those which
may have resulted from ingestion of food, but excluding false positives which
resulted from medication legitimately prescribed, indicates a violation of the
contract.
(2) Attendance is required a minimum of three times per week at an Alcoholics
Anonymous, Narcotics Anonymous, and/or similar support group meeting.
(3) The program shall immediately report to the Board any
violations of the contract and/or lack of cooperation.
(B) Debra Lynn Cooper must demonstrate satisfactory
proof to the Board that she is no longer addicted to or abusing liquor or drugs
or impaired physically or mentally to such a degree as to render her unfit to
practice pharmacy.
(C) Debra Lynn Cooper must provide, at the
reinstatement petition hearing, documentation of the following:
(1) Compliance with the contract required above (e.g.-proof of
giving the sample within twelve hours of notification and copies of all drug
screen reports, meeting attendance records, treatment program reports, etc.);
(2) Compliance with the continuing pharmacy education requirements
set forth in Chapter 4729-7 of the Ohio Administrative Code as applicable and
in effect on the date of petitioning the Board for reinstatement;
(3) Compliance with the terms of this Order.
(D) If reinstatement is not accomplished within three years of the
effective date of this Order, Debra Lynn Cooper must show successful completion
of the NAPLEX examination or an equivalent examination approved by the Board.
THIS ORDER WAS
APPROVED BY A VOTE OF THE STATE BOARD OF PHARMACY.
MOTION CARRIED.
SO ORDERED.
The motion was seconded by Mr. Giacalone and approved by the Board (Aye-6/Nay-2).
RES. 2002-050 Mr. Braylock then moved that the Board issue the following Order in the matter of CVS/pharmacy #3484:
ORDER OF THE STATE BOARD OF PHARMACY
(Docket
No. D-010313-049)
In
The Matter Of:
CVS/PHARMACY #3484
c/o
Ojinika I. Mora, R.Ph.
564
Livingston Avenue
Columbus,
Ohio 43215
(T.D. No. 02-0137150)
INTRODUCTION
THE MATTER OF CVS/PHARMACY #3484 CAME FOR
CONSIDERATION ON OCTOBER 2, 2001, BEFORE THE FOLLOWING MEMBERS OF THE BOARD:
ANN D. ABELE, R.Ph. (presiding); DIANE C. ADELMAN, R.Ph.; GREGORY BRAYLOCK,
R.Ph.; SUZANNE R. EASTMAN, R.Ph.; ROBERT P. GIACALONE, R.Ph.; LAWRENCE J. KOST,
R.Ph.; NATHAN S. LIPSYC, R.Ph.; DOROTHY S. TEATER, PUBLIC MEMBER; AND JAMES E.
TURNER, R.Ph.
NO ONE WAS PRESENT FOR CVS/PHARMACY #3484, NOR WAS
IT REPRESENTED BY COUNSEL. THE STATE OF
OHIO WAS REPRESENTED BY SALLY ANN STEUK, ASSISTANT ATTORNEY GENERAL.
SUMMARY OF EVIDENCE
(A) Testimony
State's Witnesses:
(1) Christopher Reed, Ohio State Board of Pharmacy
Respondent's Witnesses:
(1) None
(B) Exhibits
State's Exhibits:
(1) Exhibit 1C--Copy of five-page Notice of Opportunity for Hearing
letter dated March 13, 2001.
(2) Exhibit 1C-A--Two-page Written Contentions letter from John
Ahler, R.Ph. dated April 10, 2001.
(3) Exhibit 1C-B--Copy of Dangerous Drug Distributors Computer Record
of CVS/pharmacy #3484 dated February 27, 2001.
(4) Exhibit 2--Five-page Dangerous Drug Distributor Inspection
Report of CVS/Pharmacy #3484 dated October 6, 2000.
(5) Exhibit 3--Copy of two-page Pink Sheet Response dated December
8, 2000.
(6) Exhibit 4--Two-page Dangerous Drug Distributor Inspection
Report of Revco Discount Drug Center dated July 28, 1997; Prescription Room
Barricade Inspection Report for Terminal Distributor License No. 02-0137150
dated July 28, 1997.
(7) Exhibit 5--Copy of two-page Dangerous Drug Distributor
Inspection Report of Revco Discount
Drug Center dated July 28, 1997 with handwritten response on reverse side of
page one, not dated.
(8) Exhibit 6--DEA 222 Order Form No.
980109242 of CVS/pharmacy #3484 dated January 19, 2000.
(9) Exhibit 7--DEA 222 Order Form No.
980109245 of CVS/pharmacy #3484 dated March 8, 2000.
(10) Exhibit 8--DEA 222 Order Form No. 980109246 of CVS/pharmacy #3484
dated March 12, 2000.
(11) Exhibit 9--DEA 222 Order Form No. 980109247 of CVS/pharmacy #3484
dated March 22, 2000.
(12) Exhibit 10--DEA 222 Order Form No. 980109248 of CVS/pharmacy
#3484 dated March 31, 2000.
(13) Exhibit 11--DEA 222 Order Form No. 980109249 of CVS/pharmacy
#3484 dated April 12, 2000.
(14) Exhibit 12--DEA 222 Order Form No. 980924246 of CVS/pharmacy
#3484 dated April 18, 2000.
(15) Exhibit 13--DEA 222 Order Form No. 980924247 of CVS/pharmacy
#3484 dated May 2, 2000.
(16) Exhibit 14--DEA 222 Order Form No. 980924248 of CVS/pharmacy
#3484 dated May 3, 2000.
(17) Exhibit 15--DEA 222 Order Form No. 980924249 of CVS/pharmacy
#3484 dated May 21, 2000.
(18) Exhibit 16--DEA 222 Order Form No. 980924250 of CVS/pharmacy
#3484 dated June 4, 2000.
(19) Exhibit 17--DEA 222 Order Form No. 980924252 of CVS/pharmacy
#3484 dated July 20, 2000.
(20) Exhibit 18--DEA 222 Order Form No. 980924253 of CVS/pharmacy
#3484 dated July 30, 2000.
(21) Exhibit 19--DEA 222 Order Form No. 980924254 of CVS/pharmacy
#3484 dated August 8, 2000.
(22) Exhibit 20--DEA 222 Order Form No. 980924255 of CVS/pharmacy
#3484 dated August 8, 2000.
(23) Exhibit 21--DEA 222 Order Form No. 980924256 of CVS/pharmacy
#3484 dated August 23, 2000.
(24) Exhibit 22--DEA 222 Order Form No. 980924257 of CVS/pharmacy
#3484 dated September 10, 2000.
(25) Exhibit 23--DEA 222 Order Form No. 980924258 of CVS/pharmacy
#3484 dated September 22, 2000.
(26) Exhibit 24--DEA 222 Order Form No. 980924259 of CVS/pharmacy
#3484 dated September 24, 2000.
(27) Exhibit 25--DEA 222 Order Form No. 980924242 of CVS/pharmacy
#3484 dated September 28, 2000.
(28) Exhibit 26--DEA 222 Order Form No. 980924243 of CVS/pharmacy
#3484 dated October 3, 2000.
(29) Exhibit 27--Seven-page CVS/Revco #3484 Prescription Register
report covering Midnight through Noon of September 28, 2000, dated September
29, 2000.
(30) Exhibit 28--Nine-page CVS/Revco #3484 Prescription Register
report covering Midnight through Noon of October 5, 2000, dated October 6,
2000.
(31) Exhibit 29--Two-page CVS/Revco #3484 Pharmacist's Statement
report for Ray Bozeman covering January 1, 2000 through October 6, 2000, dated
October 6, 2000.
(32) Exhibit 30--Prescription No. C 590834 00 for Roy Bozeman dated
September 20, 2000.
(33) Exhibit 31--CVS Third Party/Consultation Log with stickers dated
from August 29, 2000 to October 6, 2000.
(34) Exhibit 32--Copy of three-page Settlement Agreement with the
State Board of Pharmacy, Docket No. D-990721-005, in the matter of CVS/Pharmacy
#3484 effective November 8, 1999.
(35) Exhibit 33--CVS/Revco #3484 Pharmacist’s Statement report for
Greg Daniel covering January 1, 2000 through October 6, 2000, dated October 6,
2000.
(36) Exhibit 34--Prescription No. C 592163 00 for
Greg Daniel dated October 6, 2000.
(37) Exhibit 35--CVS/Revco #3484 Pharmacist’s Statement report for Margaret
M. Jackson covering January 1, 2000 through October 6, 2000, dated October 6,
2000.
(38) Exhibit 36--Prescription No. 592161 00 for
Margaret M. Jackson dated October 6, 2000.
(39) Exhibit 37--Dangerous Drug Distributor Inspection Report for
CVS/Pharmacy #3484 dated August 3, 2001.
Respondent's Exhibits:
(1) None
FINDINGS
OF FACT
After having heard the testimony, observed the
demeanor of the witness, considered the evidence, and weighed the credibility
of each, the State Board of Pharmacy finds the following to be fact:
(1) On March 13, 2001, CVS/pharmacy #3484 was notified by letter of
its right to a hearing, its rights in such hearing, and its right to submit any
contentions in writing.
(2) As demonstrated by return receipt dated March 14, 2001,
CVS/pharmacy #3484 received the letter of March 13, 2001, informing it of the
allegations against the pharmacy, and its rights.
(3) CVS/pharmacy #3484 has submitted its contentions in writing by
letter dated April 10, 2001, but has not requested a hearing in this matter.
(4) Records of the State Board of Pharmacy indicate that
CVS/pharmacy #3484 is licensed with the Board and Ojinika I. Mora is the
Responsible Pharmacist at CVS/pharmacy #3484 pursuant to Rule 4729-5-11 of the
Ohio Administrative Code and Sections 4729.27 and 4729.55 of the Ohio Revised
Code. Board records further reflect
that CVS/pharmacy #3484 had previously entered into a Settlement Agreement with
the State Board of Pharmacy regarding violations of patient counseling and
prospective drug utilization review (DUR) rules.
(5) CVS/pharmacy #3484 did, on or about October 6, 2000, and dates
preceding, fail to keep a complete and accurate record of all controlled
substances, to wit: the most recent DEA biennial inventory had been taken on
May 1, 1997. Such conduct is in
violation of Section 3719.07 of the Ohio Revised Code, Rule 4729-9-14 of the
Ohio Administrative Code, and Section 1304.11 of the Code of Federal
Regulations.
(6) CVS/pharmacy #3484 did, on or about February 21, 2000, upon the
change of the Responsible Pharmacist, fail to take a complete inventory of all
controlled substances on hand. Such
conduct is in violation of Rule 4729-5-11(C)(2) of the Ohio Administrative
Code.
(7) CVS/pharmacy #3484 did, on or about October 6, 2000, and dates
preceding, fail to maintain the minimum standards for a pharmacy, to wit: the
pharmacy did not possess a copy of current federal and state laws, regulations,
and rules governing the legal distribution of drugs in Ohio. The pharmacy’s law book had not been updated
since August 1998. CVS/pharmacy #3484
had been previously given written warning for a similar violation on July 28,
1997. Such conduct is in violation of
Rule 4729-9-02 of the Ohio Administrative Code.
(8) CVS/pharmacy #3484 did, from January 19, 2000, through October
3, 2000, fail to properly execute Schedule II controlled substance order forms,
to wit: when drugs were received by the pharmacy pursuant to DEA 222 Order
Forms, the following forms were not completed as to the number of packages
received or the date received:
DEA 222 Order Form No.
980109242 [01-19-00]
DEA 222 Order Form No.
980109245 [03-08-00]
DEA 222 Order Form No.
980109246 [03-12-00]
DEA 222 Order Form No.
980109247 [03-22-00]
DEA 222 Order Form No. 980109248 [03-31-00]
DEA 222 Order Form No.
980109249 [04-12-00]
DEA 222 Order Form No.
980924246 [04-18-00]
DEA 222 Order Form No.
980924247 [05-02-00]
DEA 222 Order Form No.
980924248 [05-03-00]
DEA 222 Order Form No.
980924249 [05-21-00]
DEA 222 Order Form No.
980924250 [06-04-00]
DEA 222 Order Form No.
980924252 [07-20-00]
DEA 222 Order Form No.
980924253 [07-30-00]
DEA 222 Order Form No.
980924254 [08-08-00]
DEA 222 Order Form No.
980924255 [08-08-00]
DEA 222 Order Form No.
980924256 [08-23-00]
DEA 222 Order Form No.
980924257 [09-10-00]
DEA 222 Order Form No.
980924258 [09-22-00]
DEA 222 Order Form No.
980924259 [09-24-00]
DEA 222 Order Form No.
980924242 [09-28-00]
DEA 222 Order Form No.
980924243 [10-03-00]
Such conduct is in violation of
Section 3719.07 of the Ohio Revised Code, Rule 4729-9-14 of the Ohio
Administrative Code, and Section 1305.06 of the Code of Federal Regulations.
(9) CVS/pharmacy #3484 did, from September 28, 2000, through
October 6, 2000, fail to have its dispensing pharmacists sign daily computer
printouts, to wit: pharmacists were signing the daily printouts for each
other. Such conduct is in violation of
Rule 4729-5-28(C)(4) of the Ohio Administrative Code.
(10) CVS/pharmacy #3484 did, on or about October 6, 2000, fail to
perform or otherwise offer patient counseling, to wit: when dispensing
medications to a patient pursuant to prescription number 590834, pharmacists
failed to offer patient counseling.
CVS/pharmacy #3484 had been given written warning on July 28, 1997, and
also had, on November 8, 1999, entered into a Settlement Agreement with the
Board to resolve patient counseling issues.
Such conduct is in violation of Rule 4729-5-22 of the Ohio
Administrative Code.
(11) CVS/pharmacy #3484 did, on or about October 6, 2000, fail to
perform or otherwise offer patient counseling, to wit: when dispensing
medications to a patient pursuant to prescription number 592163, pharmacists
failed to offer patient counseling.
CVS/pharmacy #3484 had been given written warning on July 28, 1997, and
also had, on November 8, 1999, entered into a Settlement Agreement with the
Board to resolve patient counseling issues. Such conduct is in violation of
Rule 4729-5-22 of the Ohio Administrative Code.
(12) CVS/pharmacy #3484 did, on or about October 6, 2000, fail to
perform or otherwise offer patient counseling, to wit: when dispensing
medications to a patient pursuant to prescription number 592161, pharmacists
failed to offer patient counseling.
CVS/pharmacy #3484 had been given written warning on July 28, 1997, and
also had, on November 8, 1999, entered into a Settlement Agreement with the
Board to resolve patient counseling issues.
Such conduct is in violation of Rule 4729-5-22 of the Ohio
Administrative Code.
CONCLUSIONS OF LAW
(1) Upon consideration of the record as a whole, the State Board of
Pharmacy concludes that paragraphs (5) through (12) of the Findings of Fact
constitute violating rules of the Board as provided in Division (A)(2) of
Section 4729.57 of the Ohio Revised Code.
(2) Upon consideration of the record as a whole, the State Board of
Pharmacy concludes that paragraphs (5) and (8) of the Findings of Fact
constitute violating provisions of the federal drug abuse control laws and Chapter
3719. of the Revised Code as provided in Division (A)(5) of Section 4729.57 of
the Ohio Revised Code.
(3) Upon
consideration of the record as a whole, the State Board of Pharmacy concludes
that paragraphs (5) through (7) of the Findings of Fact constitute ceasing to
satisfy the qualifications of a terminal distributor of dangerous drugs set
forth in Section 4729.55 of the Revised Code as provided in Division (A)(7) of
Section 4729.57 of the Ohio Revised Code.
ACTION
OF THE BOARD
Pursuant to Section 4729.57
of the Ohio Revised Code, the State Board of Pharmacy takes the following
actions in the matter of CVS/pharmacy #3484:
(A) On the basis of the Findings of Fact and paragraphs (1) and (2)
of the Conclusions of Law set forth above, the State Board of Pharmacy
hereby imposes a monetary penalty of
seven thousand dollars ($7,000.00) on CVS/pharmacy #3484 and payment of the
monetary penalty is due and owing within thirty days of the mailing of this
Order. The remittance should be made
payable to the "Treasurer, State of Ohio" and mailed with the
enclosed form to the State Board of Pharmacy, 77 South High Street, Room 1702,
Columbus, Ohio 43215-6126.
(B) On the basis of the Findings of Fact and paragraph (3) of the
Conclusions of Law set forth above, the State Board of Pharmacy hereby suspends
indefinitely the Terminal Distributor of Dangerous Drugs license, No.
02-0137150, held by CVS/pharmacy #3484 effective as of the date of the mailing
of this Order.
(1) The Board will stay the suspension provided that CVS/pharmacy
#3484, corrects all violations and installs a new responsible pharmacist within
ten days of the mailing of this Order.
(2) After an inspection by the Board determines compliance with
this Order, CVS/pharmacy #3484 will have quarterly inspections by the Board for
one year.
(3) If an inspection determines non-compliance with this Order,
CVS/pharmacy #3484 must surrender its Terminal Distributor license, No.
02-0137150, to the Board and the suspension will continue until CVS/pharmacy
#3484 meets all the conditions set forth in paragraph (B)(1) above.
THIS ORDER WAS
APPROVED BY A VOTE OF THE STATE BOARD OF PHARMACY.
MOTION CARRIED.
SO ORDERED.
The motion was seconded by Ms. Eastman and approved by the Board (Aye-8/Nay-0).
9:01 a.m.
The Board took a brief recess.
9:10 a.m.
The Board was joined by Assistant Attorney General Sally Ann Steuk for the purpose of conducting an adjudication hearing in accordance with Ohio Revised Code Chapters 119. and 4729. in the matter of Gerald R. Poorbaugh, R.Ph., Sebring.
11:29 a.m.
The hearing ended and the record was closed. The Board recessed for lunch.
12:48 p.m.
The Board reconvened in Room 1919 with all members present. Mr. Kost moved that the Board go into Executive Session for the purpose of the investigation of complaints regarding licensees and registrants pursuant to Section 121.22(G)(1) of the Revised Code. The motion was seconded by Ms. Eastman and a roll call vote was conducted by President Abele as follows: Adelman-Yes, Braylock-Yes, Eastman-Yes, Giacalone-Yes, Lipsyc-Yes, Kost-Yes, Teater-Yes, and Turner-Yes.
12:50 p.m.
RES. 2002-051 The Executive Session ended and the meeting was opened to the public. Mr. Turner moved that, pursuant to Section 3719.121 of the Revised Code, the Board summarily suspend the license to practice pharmacy belonging to George Leonard Plataz, R.Ph. (03-2-11512) due to the fact that a continuation of his professional practice presents a danger of immediate and serious harm to others. The motion was seconded by Mrs. Teater and approved by the Board (Aye-8/Nay-0).
RES. 2002-052 Mrs. Teater then moved that, pursuant to Section 3719.121 of the Revised Code, the Board summarily suspend the license to practice pharmacy belonging to Foster Farone, R.Ph. (03-2-21590) due to the fact that a continuation of his professional practice presents a danger of immediate and serious harm to others. The motion was seconded by Mr. Lipsyc and approved by the Board (8-0).
1:00 p.m.
The Board was joined by the following representatives of the Council of Ohio Colleges of Pharmacy for a discussion of items of mutual interest:
Alan Escovitz, Executive Director of the Council; John Cassidy, Sylvan Frank, and Ken Hale from the Ohio State University; Dan Acosta and Robert Lee from the University of Cincinnati; Johnny Early and Kurt Black from the University of Toledo; and Bob Bryant from Ohio Northern University.
2:14 p.m.
The meeting with the Council ended and the Board took a brief recess.
2:25 p.m.
RES. 2002-053 Mr. McMillen distributed the following list of the reciprocity candidates from the September meeting who attended the special meeting on September 18, 2001 that had been authorized by the Board:
JODY BENTLEY ADKINS |
|
KENTUCKY |
DAVID ANDREW BRANHAM |
|
WEST VIRGINIA |
MOLLY KATHLEEN CONLIN |
|
MISSOURI |
RICHARD MICHAEL DROZD |
|
PENNSYLVANIA |
ROBERT FIELDS DUVALL |
|
VIRGINIA |
ANTHONY JOSEPH GAROFALI |
|
MICHIGAN |
CHESTER LEE PARKER |
|
KENTUCKY |
LARRY ALAN VANHORN |
|
INDIANA |
STANLEY JAMES VOTAW |
|
INDIANA |
BRETTON CLARK WALBERG |
|
PENNSYLVANIA |
RES. 2002-054 Mr. Lipsyc and Mr. McMillen discussed a request from a group wishing to be approved as a provider of continuing pharmacy education (CPE) by the Board. After discussion, Mr. Lipsyc moved that the Board approve the application presented by the Ohio Society of Oncology Pharmacists/Hudson to be a provider of continuing pharmacy education. The motion was seconded by Mrs. Adelman and approved by the Board (Aye-8/Nay-0).
RES. 2002-055 Mr. McMillen then presented a request from Karine Khachapuridze asking for Board approval of internship hours worked prior to successful completion of the FPGEE. Since Ms. Khachapuridze was enrolled as a student in an Ohio college of pharmacy while these hours were obtained, Mrs. Adelman moved that the internship hours be allowed. The motion was seconded by Ms. Eastman and approved by the Board (Aye-8/Nay-0).
Mr. Kost gave a report on the Nursing Board Committee on Prescriptive Governance.
Ms. Abele reported that there had been no Nursing Board Formulary Committee meeting.
RES. 2002-056 Mr. Giacalone then moved that the Board adopt a policy that copies of all future Notices of Opportunity For Hearing and Board Orders issued under Chapter 119 of the Revised Code be mailed to the CEO of the employer or company involved at the address of the corporate headquarters. The motion was seconded by Mr. Braylock and approved by the Board (Aye-8/Nay-0).
2:57 a.m.
The Board took a brief recess.
3:06 p.m.
The meeting resumed. Mrs. Adelman moved that the Board go into Executive Session for the purpose of the investigation of complaints regarding licensees and registrants pursuant to Section 121.22(G)(1) of the Revised Code. The motion was seconded by Mrs. Teater and a roll call vote was conducted by President Abele as follows: Adelman-Yes, Braylock-Yes, Eastman-Yes, Giacalone-Yes, Lipsyc-Yes, Kost-Yes, Teater-Yes, and Turner-Yes.
4:50 p.m.
RES. 2002-057 The Executive Session ended and the meeting was opened to the public. Ms. Eastman moved that the Board adopt the following Order in the matter of Ojinika I. Mora, R.Ph.:
ORDER OF THE STATE BOARD OF PHARMACY
(Docket
No. D-010319-056)
In
The Matter Of:
OJINIKA I. MORA, R.Ph.
55
Woodland Avenue
Columbus,
Ohio 43203
(R.Ph. No. 03-1-12478)
INTRODUCTION
THE MATTER OF OJINIKA I. MORA CAME FOR CONSIDERATION
ON OCTOBER 2, 2001, BEFORE THE FOLLOWING MEMBERS OF THE BOARD: ANN D. ABELE,
R.Ph.; (presiding); DIANE C. ADELMAN, R.Ph.; GREGORY BRAYLOCK, R.Ph.; SUZANNE
R. EASTMAN, R.Ph.; ROBERT P. GIACALONE, R.Ph.; LAWRENCE J. KOST, R.Ph.; NATHAN
S. LIPSYC, R.Ph.; DOROTHY S. TEATER, PUBLIC MEMBER; AND JAMES E. TURNER, R.Ph.
OJINIKA I. MORA WAS NOT
PRESENT NOR WAS SHE REPRESENTED BY COUNSEL.
THE STATE OF OHIO WAS REPRESENTED BY SALLY ANN STEUK, ASSISTANT ATTORNEY
GENERAL.
SUMMARY OF EVIDENCE
(A) Testimony
State's Witnesses:
(1) Christopher Reed, Ohio State Board of Pharmacy
Respondent's Witnesses:
(1) None
(B) Exhibits
State's Exhibits:
(1) Exhibit 1M--Copy of five-page Notice of Opportunity for Hearing
letter dated March 19, 2001.
(2) Exhibit 1M-A--Copy of Pharmacist Computer File Front Page of
Ojinika I. Mora.
(3) Exhibit 2--Five-page Dangerous Drug Distributor Inspection
Report of CVS/Pharmacy # 3484 dated October 6, 2000.
(4) Exhibit 3--Copy of two-page Pink Sheet Response dated December
8, 2000.
(5) Exhibit 4--Two-page Dangerous Drug Distributor Inspection Report
of Revco Discount Drug Center dated July 28, 1997; Prescription Room Barricade
Inspection Report for Terminal Distributor License No. 02-0137150 dated July
28, 1997.
(6) Exhibit 5--Copy of two-page Dangerous Drug Distributor
Inspection Report of Revco Discount Drug Center dated July 28,1997 with
handwritten response on reverse side of page one, not dated.
(7) Exhibit 6--DEA 222 Order Form No. 980109242 of CVS/pharmacy
#3484 dated January 19, 2000.
(8) Exhibit 7--DEA 222 Order Form No. 980109245 of CVS/pharmacy
#3484 dated March 8, 2000.
(9) Exhibit 8--DEA 222 Order Form No. 980109246 of CVS/pharmacy
#3484 dated March 12, 2000.
(10) Exhibit 9--DEA 222 Order Form No. 980109247 of CVS/pharmacy #3484
dated March 22, 2000.
(11) Exhibit 10--DEA 222 Order Form No. 980109248 of CVS/pharmacy
#3484 dated March 31, 2000.
(12) Exhibit 11--DEA 222 Order Form No. 980109249 of CVS/pharmacy
#3484 dated April 12, 2000.
(13) Exhibit 12--DEA 222 Order Form No. 980924246 of CVS/pharmacy
#3484 dated April 18, 2000.
(14) Exhibit 13--DEA 222 Order Form No. 980924247 of CVS/pharmacy
#3484 dated May 2, 2000.
(15) Exhibit 14--DEA 222 Order Form No. 980924248 of CVS/pharmacy
#3484 dated May 3, 2000.
(16) Exhibit 15--DEA 222 Order Form No. 980924249 of CVS/pharmacy
#3484 dated May 21, 2000.
(17) Exhibit 16--DEA 222 Order Form No. 980924250 of CVS/pharmacy
#3484 dated June 4, 2000.
(18) Exhibit 17--DEA 222 Order Form No. 980924252 of CVS/pharmacy
#3484 dated July 20, 2000.
(19) Exhibit 18--DEA 222 Order Form No. 980924253 of CVS/pharmacy
#3484 dated July 30, 2000.
(20) Exhibit 19--DEA 222 Order Form No. 980924254
of CVS/pharmacy #3484 dated August 8, 2000.
(21) Exhibit 20--DEA 222 Order Form No. 980924255 of CVS/pharmacy
#3484 dated August 8, 2000.
(22) Exhibit 21--DEA 222 Order Form No. 980924256 of CVS/pharmacy
#3484 dated August 23, 2000.
(23) Exhibit 22--DEA 222 Order Form No. 980924257 of CVS/pharmacy
#3484 dated September 10, 2000.
(24) Exhibit 23--DEA 222 Order Form No. 980924258 of CVS/pharmacy
#3484 dated September 22, 2000.
(25) Exhibit 24--DEA 222 Order Form No. 980924259 of CVS/pharmacy
#3484 dated September 24, 2000.
(26) Exhibit 25--DEA 222 Order Form No. 980924242 of CVS/pharmacy
#3484 dated September 28, 2000.
(27) Exhibit 26--DEA 222 Order Form No. 980924243 of CVS/pharmacy
#3484 dated October 3, 2000.
(28) Exhibit 27--Seven-page CVS/Revco #3484 Prescription Register
report covering Midnight through Noon of September 28, 2000, dated September
29, 2000.
(29) Exhibit 28--Nine-page CVS/Revco #3484 Prescription Register report
covering Midnight through Noon of October 5, 2000, dated October 6, 2000.
(30) Exhibit 29--Two-page CVS/Revco #3484 Pharmacist's Statement
report for Ray Bozeman covering January 1, 2000 through October 6, 2000, dated
October 6, 2000.
(31) Exhibit 30--Prescription No. C 590834 00 for Roy Bozeman dated
September 20, 2000.
(32) Exhibit 31--CVS Third Party/Consultation Log with stickers dated
from August 29, 2000 to October 6, 2000.
(33) Exhibit 32--Copy of three-page Settlement Agreement with the
State Board of Pharmacy, Docket No. D-990721-005 in the matter of CVS/Pharmacy
#3484 effective November 8, 1999.
(34) Exhibit 33--CVS/Revco #3484 Pharmacist’s
Statement report for Greg Daniel covering January 1, 2000 through October 6,
2000, dated October 6, 2000.
(35) Exhibit 34--Prescription No. C 592163 00 for Greg Daniel dated
October 6, 2000.
(36) Exhibit 35--CVS/Revco #3484 Pharmacist’s Statement report for
Margaret M. Jackson covering January 1, 2000 through October 6, 2000, dated
October 6, 2000.
(37) Exhibit 36--Prescription No. 592161 00 for Margaret M. Jackson
dated October 6, 2000.
(38) Exhibit 37--Dangerous Drug Distributor Inspection Report for
CVS/Pharmacy #3484 dated August 3, 2001.
Respondent's Exhibits:
(1) None
FINDINGS
OF FACT
After having heard the testimony, observed the
demeanor of the witness, considered the evidence, and weighed the credibility
of each, the State Board of Pharmacy finds the following to be fact:
(1) On March 19, 2001, Ojinika I. Mora was notified by letter of
her right to a hearing, her rights in such hearing, and her right to submit any
contentions in writing.
(2) As demonstrated by personal delivery record dated May 1, 2001,
Ojinika I Mora received the letter of March 19, 2001, informing her of the allegations
against her, and her rights.
(3) Ojinika I Mora has not responded in any manner to the letter of
March 19, 2001, and has not requested a hearing in this matter.
(4) Records of the State Board of Pharmacy indicate that Ojinika I.
Mora was originally licensed by the State of Ohio on August 10, 1977, pursuant
to examination, and is currently licensed to practice pharmacy in the state of
Ohio. Further, Ojinika I. Mora is the
Responsible Pharmacist at CVS/pharmacy #3484, 564 Livingston Avenue, Columbus,
Ohio 43215, pursuant to Sections 4729.27 and 4729.55 of the Ohio Revised Code
and Rule 4729-5-11 of the Ohio Administrative Code.
(5) Ojinika I. Mora as Responsible Pharmacist did, on or about
October 6, 2000, and dates preceding, fail to keep a complete and accurate
record of all controlled substances.
The most recent DEA biennial inventory had been taken on May 1,
1997. Such conduct is in violation of
Section 3719.07 of the Ohio Revised Code, Rule 4729-9-14 of the Ohio
Administrative Code, and Section 1304.11 of the Code of Federal Regulations.
(6) Ojinika I. Mora as Responsible Pharmacist did, on or about
February 21, 2000, upon becoming the Responsible Pharmacist, fail to take a
complete inventory of all controlled substances on hand. Such conduct is in violation of Rule
4729-5-11(C)(2) of the Ohio Administrative Code.
(7) Ojinika I. Mora as Responsible Pharmacist did, on or about
October 6, 2000, and dates preceding, fail to maintain the minimum standards
for a pharmacy, to wit: the pharmacy did not possess a copy of current federal
and state laws, regulations, and rules governing the legal distribution of
drugs in Ohio. The pharmacy’s law book
had not been updated since August 1998.
CVS/pharmacy #3484 had been previously given written warning for a
similar violation on July 28, 1997.
Such conduct is in violation of Rule 4729-9-02 of the Ohio
Administrative Code.
(8) Ojinika
I. Mora as Responsible Pharmacist did, from March 8, 2000, through October 3,
2000, fail to properly execute Schedule II controlled substance order forms, to
wit: when drugs were received by the pharmacy pursuant to DEA 222 Order Forms,
the following forms were not completed as to the number of packages received or
the date received.
DEA 222 Order Form No.
980109245 [03-08-00]
DEA 222 Order Form No.
980109246 [03-12-00]
DEA 222 Order Form No.
980109247 [03-22-00]
DEA 222 Order Form No.
980109248 [03-31-00]
DEA 222 Order Form No.
980109249 [04-12-00]
DEA 222 Order Form No.
980924246 [04-18-00]
DEA 222 Order Form No.
980924247 [05-02-00]
DEA 222 Order Form No.
980924248 [05-03-00]
DEA 222 Order Form No.
980924249 [05-21-00]
DEA 222 Order Form No.
980924250 [06-04-00]
DEA 222 Order Form No.
980924252 [07-20-00]
DEA 222 Order Form No.
980924253 [07-30-00]
DEA 222 Order Form No.
980924254 [08-08-00]
DEA 222 Order Form No.
980924255 [08-08-00]
DEA 222 Order Form No.
980924256 [08-23-00]
DEA 222 Order Form No.
980924257 [09-10-00]
DEA 222 Order Form No.
980924258 [09-22-00]
DEA 222 Order Form No.
980924259 [09-24-00]
DEA 222 Order Form No.
980924242 [09-28-00]
DEA 222 Order Form No.
980924243 [10-03-00]
Such conduct is in violation
of Section 3719.07 of the Ohio Revised Code, Rule 4729-9-14 of the Ohio
Administrative Code, and Section 1305.06 of the Code of Federal Regulations.
(9) Ojinika I. Mora as Responsible Pharmacist did, from September
28, 2000, through October 6, 2000, fail to have dispensing pharmacists sign
daily computer printouts, to wit: pharmacists were signing the daily printouts
for each other. Such conduct is in
violation of Rule 4729-5-28(C)(4) of the Ohio Administrative Code.
(10) Ojinika I. Mora as Responsible Pharmacist did, on or about
October 6, 2000, fail to perform or otherwise offer patient counseling, to wit:
when dispensing medications to a patient pursuant to prescription number
590834, pharmacists failed to offer patient counseling. CVS/pharmacy #3484 had been given written
warning on July 28, 1997, and also had, on November 8, 1999, entered into a
Settlement Agreement with the Board to resolve patient counseling issues. Such conduct is in violation of Rule
4729-5-22 of the Ohio Administrative Code
(11) Ojinika I. Mora as Responsible Pharmacist did, on or about October
6, 2000, fail to perform or otherwise offer patient counseling, to wit: when
dispensing medications to a patient pursuant to prescription number 592163,
pharmacists failed to offer patient counseling. CVS/pharmacy #3484 had been given written warning on July 28,
1997, and also had, on November 8, 1999, entered into a Settlement Agreement
with the Board to resolve patient counseling issues. Such conduct is in violation of Rule 4729-5-22 of the Ohio
Administrative Code.
(12) Ojinika I. Mora as Responsible Pharmacist did, on or about October
6, 2000, fail to perform or otherwise offer patient counseling, to wit: when
dispensing medications to a patient pursuant to prescription number 592161,
pharmacists failed to offer patient counseling. CVS/pharmacy #3484 had been given written warning on July 28,
1997, and also had, on November 8, 1999, entered into a Settlement Agreement
with the Board to resolve patient counseling issues. Such conduct is in violation of Rule 4729-5-22 of the Ohio
Administrative Code.
CONCLUSIONS
OF LAW
(1) Upon
consideration of the record as a whole, the State Board of Pharmacy concludes
that paragraphs (5) through (12) of the Findings of Fact constitute being
guilty of unprofessional conduct in the practice of pharmacy as provided in
Division (A)(2) of Section 4729.16 of the Ohio Revised Code.
(2) Upon consideration of the record as a whole, the State Board of
Pharmacy concludes that paragraphs (5) and (8) of the Findings of Fact
constitute being guilty of willfully violating, conspiring to violate, attempting
to violate, or aiding and abetting the violation of provisions of Chapter 3719.
of the Revised Code as provided in Division (A)(5) of Section 4729.16 of the
Ohio Revised Code.
ACTION
OF THE BOARD
Pursuant to Section 4729.16 of the Ohio Revised
Code, and on the basis of the Findings of Fact and Conclusions of Law set forth
above, the State Board of Pharmacy hereby suspends indefinitely the pharmacist
identification card, No. 03-03-1-12478, held by Ojinika I. Mora and such
suspension is effective as of the date of the mailing of this Order.
(A) Ojinika I. Mora, pursuant to Rule 4729-9-01(F) of the Ohio
Administrative Code, may not be employed by or work in a facility licensed by
the State Board of Pharmacy to possess or distribute dangerous drugs during such
period of suspension.
(B) Ojinika I. Mora, pursuant to Section 4729.16(B) of the Ohio
Revised Code, must return the identification card and license (wall
certificate) to the office of the State Board of Pharmacy within ten days after
receipt of this Order unless the Board office is already in possession of
both. The identification card and wall
certificate should be sent by certified mail, return receipt requested.
Further, the Board will consider suspending the
suspension provided that Ojinika I. Mora appears before the State Board of
Pharmacy. If reinstatement is not
accomplished within three years of the effective date of this Order, Ojinika I.
Mora must show, at the time of her appearance before the Board, successful
completion of the NAPLEX examination or an equivalent examination approved by
the Board.
THIS ORDER WAS
APPROVED BY A VOTE OF THE STATE BOARD OF PHARMACY.
MOTION CARRIED.
SO ORDERED.
The motion was seconded by Mrs. Teater and approved by the Board (Aye-8/Nay-0).
RES. 2002-058 Mrs. Adelman moved that the Board adopt the following Order in the matter of James W. Smetana, R.Ph.:
ORDER OF THE STATE BOARD OF
PHARMACY
(Docket No. D-010222-060)
In The Matter Of:
JAMES W. SMETANA, R.Ph.
244 Lowry Drive
West Milton, Ohio 45383
(R.Ph. No. 03-3-11602)
INTRODUCTION
THE
MATTER OF JAMES W. SMETANA CAME FOR HEARING ON SEPTEMBER 11, 2001 AND WAS
CONTINUED ON OCTOBER 2, 2001, BEFORE THE FOLLOWING MEMBERS OF THE BOARD: ANN D.
ABELE, R.Ph. (presiding); DIANE C. ADELMAN, R.Ph.; GREGORY BRAYLOCK, R.Ph.;
ROBERT P. GIACALONE, R.Ph.; LAWRENCE J. KOST, R.Ph.; NATHAN S. LIPSYC, R.Ph.;
DOROTHY S. TEATER, PUBLIC MEMBER; AND JAMES E. TURNER, R.Ph.
JAMES W. SMETANA WAS NOT REPRESENTED BY COUNSEL AND THE
STATE OF OHIO WAS REPRESENTED BY SALLY ANN STEUK, ASSISTANT ATTORNEY GENERAL.
SUMMARY OF EVIDENCE
(A) Testimony
State's Witnesses:
(1) None
Respondent's Witnesses:
(1) James W. Smetana, R.Ph, Respondent
(2) Dr. Gary Pierce, D.D.S.
(3) Ronald Smetana, R.Ph.
(B) Exhibits
State's Exhibits:
(1) Exhibit 1--Faxed Hearing Request letter from James W. Smetana
dated February 21, 2001.
(2) Exhibit 1A--Copy of two-page Hearing Schedule letter dated
February 22, 2001.
(3) Exhibit 1B--Copy of Ohio Pharmacist Computer Record of James W.
Smetana.
(4) Exhibit 1C--Copy of Hearing Schedule letter dated August 23,
2001.
(5) Exhibit 1D--Copy of Hearing Schedule letter dated September 12,
2001.
(6) Exhibit 1E--Faxed Request for Continuation letter from James W.
Smetana dated September 21, 2001.
(7) Exhibit 1F--Copy of Denied Request for Continuance letter dated
September 25, 2001.
(8) Exhibit 2--Copy of six-page Order of the State Board of
Pharmacy, Docket No. D-950802-009 in the matter of James W. Smetana, R.Ph.
dated October 30, 1995.
(9) Exhibit 3--Copy of three-page Order of the State Board of
Pharmacy, Docket No. D-990422-044 in the matter of James W. Smetana, R.Ph.
dated September 9, 1999.
(10) Exhibit 4--Two Children's Medical Center, Dayton, Ohio Controlled
Drug Inventory Sheets, Control No. 0716 and Control No. 0728.
(11) Exhibit 5--Seven Pharmacy Service Manufacturing Control Sheets
numbered as follows: Control No. 030494 dated March 4, 1995; Control No. 030794
dated March 7, 1995; Control No. 040195 dated April 1, 1995; Control No. 052395
dated May 23, 1995; Control No. 060595 dated June 5, 1995; Control No. 061495
dated June 14, 1995; and Control No. 062395 dated June 23, 1995.
(12) Exhibit 6--Five Prepackaged Pharmaceutical Item Control Record
forms with dates from June 23, 1992 to July 18, 1995.
(13) Exhibit 7--Copy of ten Toxicology Associates Inc. Laboratory
Reports for the following: Lot No. 98
collected July 5, 1995; Lot No. 98
collected July 10, 1995; Lot No. 99
collected July 10, 1995; and Lots numbered 74, 84, 90, 91, 92, 93, and
94 dated July 17, 1995.
(14) Exhibit 8--Review of Manufacturing Cards, Inventory Records and
Prepack Records report covering July
18, 1994 through July 18, 1995.
(15) Exhibit 9--Faxed The Children’s Medical Center Pharmacy
Department’s Policy & Procedure for manufacturing Tac Topical Solution
dated May 1994.
(16) Exhibit 10--Copy of three-page Indictment, State
of Ohio vs. James W. Smetana, Case No. 95-CR-3065, Montgomery County Common
Pleas Court, date illegible; copy of Summons issued to James W. Smetana dated
January 3, 1996.
(17) Exhibit 11--Copy of two-page Decision and Entry Treatment in Lieu
of Conviction, State of Ohio vs. James W. Smetana, Case No. 95-CR-3065,
Montgomery County Common Pleas Court, dated February 29, 1996.
(18) Exhibit 12--Copy of Termination Entry, State of Ohio vs. James
W. Smetana, Case No. 95-CR-3065, Montgomery County Common Pleas Court,
dated March 1, 1999.
(19) Exhibit 13--Copy of three-page Indictment, State of Ohio vs.
James W. Smetana, Case No.
97-CR-1596, Montgomery County Common Pleas Court, date illegible.
(20) Exhibit 14--Two-page copy of Entry of Waivers and Plea on
Indictment/ Entry and Order, State of Ohio vs. James W. Smetana, Case
No. 97-CR-1596, Montgomery County Common Pleas Court, dated February 17, 1998.
(21) Exhibit 15--Copy of Order of Probation, State of Ohio vs.
James W. Smetana, Case No. 97-CR-1596, Montgomery County Common Pleas
Court, dated February 26, 1999.
(22) Exhibit 16--Copy of two-page Termination Entry - Community
Control, State of Ohio vs. James W. Smetana, Case No. 97-CR-1596,
Montgomery County Common Pleas Court, dated April 6, 1998.
(23) Exhibit 17--Copy of Statement of Sheryl Vickers notarized on
October 6, 1999.
(24) Exhibit 18--Copy of Dr. Dennis E. McClure
three-page report of Jim Smetana's Personal Expenses Charged on Company Credit
Cards covering April, 1996 to June, 1997.
(25) Exhibit 19--Copy of Statement of Sheryl Vickers notarized on
August 21, 2001.
(26) Exhibit 20--Copy of five-page Order Confirming Chapter 13 Plan
and Order Allowing Attorney Fee for Debtor's Counsel, in re James W. Smetana,
Case No. 99-32150, United States Bankruptcy Court, Southern District of Ohio,
Western Division at Dayton, filed
August 5, 1999.
(27) Exhibit 21--Copy of letter from David W. Baker dated October 15,
1997.
Respondent's Exhibits:
(1) Exhibit A1--Copy of letter from James W. Smetana dated November
17, 1999; copy of Turning Point Initial Treatment Agreement of James W. Smetana
dated October 12, 1999; copy of twenty-six pages of Miami Valley Hospital
Turning Point Client Service Records of James Smetana dated August 20, 1999 to
July 17, 2001.
(2) Exhibit A2--Copy of two-page letter from Mary Spain, MS, LSW,
LPC dated August 30, 1995.
(3) Exhibit A3--Copy of letter from Jeffrey C. Owen, M.S. dated May
17, 1997; Copy of Turning Point Level II/I Treatment Contract of James Smetana
dated November 2, 1995; Copy of two-page Turning Point Treatment Plan and
Objectives form dated November 2, 1995; Copy of Master Problem List for James
Smetana with entries dated June 15, 1995 and July 6, 1995; Copy of twenty-eight
pages of Miami Valley Hospital progress notes re James Smetana dated from June
15, 1995 to June 19, 1997.
(4) Exhibit A4--Ten letters from the following: D. Scott Coffman
BA, CCDC III-E dated August 21, 2001; Dettleff Olson, D.O. dated August 21,
2001; Rachelle K. Woods dated September 4, 2001; Eric Longenecker dated
September 5, 2001; Terry Craycraft dated September 4, 2001; Gary W. Pierce,
D.D.S. dated August 23, 2001; John D. McCarthy dated July 8, 1999; Lori D.
Stickler dated July 14, 1999; Robert J. Dougherty, R.Ph. dated July 20, 1999;
Robert D. Bolte, CCDC IIIE dated September 8, 2001.
(5) Exhibit A5--Twenty-five Verification of A.A. Attendance records
dated from July 26, 1999 to August 31, 2001.
(6) Exhibit A6--Copy of eight drug screen reports for specimens
collected from Jim Smetana on November 12, 1999, March 15, 2000, May 17, 2000,
August 30, 2000, December 21, 2000, February 21, 2001, June 14, 2001, and July 31, 2001; and one
Chain-of-Custody form of James W. Smetana, date illegible.
(7) Exhibit A7--Two-page summary of Continuing Education Programs and Hours; forty-nine pages of
Continuing Pharmacy Education Certificates dated from November 19, 1996 to July
17, 2001.
(8) Exhibit A8--Copy of "Agreed Order That Modified Plan Be
Confirmed As Modified At Bar And Modifying Debtor's May 22, 2001 Modified
Plan", In Re James W. Smetana, Case No. 99-32150, United States Bankruptcy
Court, Southern District of Ohio, Western Division at Dayton, filed June 26,
2001; Copy of "Chapter 13 Trustee’s Objection To Confirmation Request For
Denial Of Confirmation And Notice Of Hearing", In Re James W. Smetana, Case
No. 99-32150, United States Bankruptcy Court, Southern District of Ohio,
Western Division at Dayton, dated June 15, 2001; copy of Statement by Jeffrey
M. Kellner, Chapter 13 Trustee, not dated; copy of four pages of paychecks and
paycheck stubs of James Smetana dated from May 2, 2001 to August 23, 2001.
(9) Exhibit A9--Letter from James Smetana dated November 17, 1999;
copy of Turning Point Initial Treatment Agreement for James W. Smetana dated
October 12, 1999; fax cover page from Turning Point Miami Valley Hospital to
Jim Smetana, not dated.
(10) Exhibit A10--Verification of A.A. Attendance record dated from
September 2, 2001 to September 10, 2001.
(11) Exhibit A11--Copy of letter to Dawn Hahn
from Jim Smetana dated July 31, 2001.
(12) Exhibit A12--Copy of letter to Dawn Hahn from Jim Smetana dated
September 17, 2001.
(13) Exhibit A13--Copy of Lab One drug screen report for specimen
collected from Jim Smetana on September
17, 2001.
(14) Exhibit A14-Copy of Verification of A.A. Attendance record dated from
September 12, 2001 to October 1, 2001.
FINDING
OF FACT
After having heard the testimony, observed the
demeanor of the witnesses, considered the evidence, and weighed the credibility
of each, the State Board of Pharmacy finds that James W. Smetana has not
complied with the terms set forth in the Order of the State Board of Pharmacy,
Docket No. D-990422-044, effective September 9, 1999, nor has he demonstrated
satisfactory proof to the Board that he is no longer addicted to or abusing
liquor or drugs or impaired physically or mentally to such a degree as to
render him unfit to practice pharmacy.
ACTION
OF THE BOARD
On the basis of the Findings of Fact set forth
above, the State Board of Pharmacy hereby denies the reinstatement petition of
James W. Smetana. Pursuant to Rule
4729-9-01(F) of the Ohio Administrative Code, James W. Smetana may not be
employed by or work in a facility licensed by the State Board of Pharmacy to
possess or distribute dangerous drugs during suspension.
Further, at the Board's August 2003 meeting or
thereafter, the Board will consider any petition presented by James W. Smetana,
pursuant to Ohio Revised Code Chapter 119., for reinstatement. The Board will only consider reinstatement
of the license to practice pharmacy in Ohio if James W. Smetana provides
documentation of continuous compliance with the Board's September 9, 1999 Order
and demonstrates satisfactory proof that he is no longer addicted to or abusing
liquor or drugs or impaired physically or mentally to such a degree as to
render him unfit to practice pharmacy.
THIS ORDER WAS
APPROVED BY A VOTE OF THE STATE BOARD OF PHARMACY.
MOTION CARRIED.
SO ORDERED.
The motion was seconded by Mr. Braylock and approved by the Board (Aye-6/Nay-1/Abstain-1[Eastman]).
RES. 2002-059 Mr. Lipsyc moved that the Board adopt the following Order in the matter of Dennis Farina, R.Ph.:
ORDER OF THE STATE BOARD OF PHARMACY
(Docket
No. D-010312-044)
In
The Matter Of:
DENNIS JAMES FARINA, R.Ph.
3826
Fargo Drive
Ashtabula,
Ohio 44004
(D.O.B. 12/08/1955)
INTRODUCTION
THE MATTER OF DENNIS JAMES FARINA CAME FOR HEARING
ON OCTOBER 2, 2001, BEFORE THE FOLLOWING MEMBERS OF THE BOARD: ANN D. ABELE,
R.Ph. (presiding); DIANE C. ADELMAN, R.Ph.; GREGORY BRAYLOCK, R.Ph.; SUZANNE R.
EASTMAN, R.Ph.; ROBERT P. GIACALONE, R.Ph.; LAWRENCE J. KOST, R.Ph.; NATHAN S.
LIPSYC, R.Ph.; DOROTHY S. TEATER, PUBLIC MEMBER; AND JAMES E. TURNER, R.Ph.
DENNIS JAMES FARINA WAS REPRESENTED BY EUGENE F.
McSHANE AND THE STATE OF OHIO WAS REPRESENTED BY SALLY ANN STEUK, ASSISTANT
ATTORNEY GENERAL.
SUMMARY OF EVIDENCE
(A) Testimony
State's Witnesses:
(1) Joann Predina, R.Ph., Ohio State Board of Pharmacy
Respondent's Witnesses:
(1) Dennis James Farina, R.Ph., Respondent
(B) Exhibits
State's Exhibits:
(1) Exhibit 1--Copy of four-page Proposal to Deny/Notice of
Opportunity for Hearing letter dated March 13, 2001.
(2) Exhibit 1A--Hearing Request letter from Dennis J. Farina
received March 21, 2001.
(3) Exhibit 1B--Copy of Hearing Schedule letter dated March 22,
2001.
(4) Exhibit 1C--Letter from Eugene F. McShane dated June 19, 2001
with Notice of Appearance, not dated.
(5) Exhibit 1D--Copy of four-page NABP Official Application For
Transfer Of Pharmaceutic Licensure to the state of Ohio; Copy of pages two, three,
and four of the NABP Preliminary Application for Transfer of Pharmaceutic
Licensure, dated January 16, 2001; Copy of Additional Space for Application
Information form completed by Dennis Farina, not dated.
(6) Exhibit 1E--Copy of Hearing Schedule letter dated September 13,
2001.
Respondent's Exhibits:
(1) Exhibit A--Copy of Commonwealth of Pennsylvania Pharmacist
Certificate No. RP-030014-L issued to Dennis James Farina October 18, 2000.
(2) Exhibit B--Eighty-nine pages of copies of Continuing Pharmacy
Education Certificates dated from September 26, 1996 to November 14, 2000.
(3) Exhibit C--Ten pages of copies of Continuing Pharmacy Education
Certificates dated from October 23, 1996 to November 20, 1997.
(4) Exhibit D--Letter from William J. Netkowicz dated August 26,
2001.
(5) Exhibit E--Letter from Patrick M. Andrews, R.Ph. dated August
30, 2001.
(6) Exhibit F--Letter from Peter A. Schumann, R.Ph. dated August
28, 2001.
(7) Exhibit G--Letter from Katherine Sahlmann, R.Ph. dated August
27, 2001.
(8) Exhibit H--Letter from Traci L. Mason dated August 30, 2001.
(9) Exhibit I--Letter from Christina C. Nyman dated August 29,
2001.
(10) Exhibit J--Six pages of copies of Kent State University Grade
Reports for Dennis Farina from 1984 through 1987.
(11) Exhibit K--Letter from Chester J. Prusinski, D.O. dated September
10, 2001.
(12) Exhibit L--Copy of two-page State Board of Pharmacy Summary of
Requirements for Licensure As An Ohio Pharmacist By Reciprocity dated January
22, 2001.
FINDINGS
OF FACT
After having heard the testimony, observed the
demeanor of the witnesses, considered the evidence, and weighed the credibility
of each, the State Board of Pharmacy finds the following to be fact:
(1) Dennis James Farina is a registered pharmacist in the state of
Pennsylvania, pursuant to examination, and on or about January 24, 2001 was
issued an NABP Official Application For Transfer Of Pharmaceutic Licensure to
the state of Ohio.
(2) Dennis James Farina has not continually practiced pharmacy in
another state as provided in Section 4729.13 of the Ohio Revised Code, to wit:
although originally licensed in Pennsylvania in 1978, Dennis James Farina did
not practice pharmacy from 1984 through 2000.
(3) Dennis James Farina has provided equivalent credentials for
registration as a pharmacist in Ohio.
ACTION
OF THE BOARD
Upon consideration of the record as a whole, the
State Board of Pharmacy hereby approves the issuance of a certificate of
registration to Dennis James Farina and, therefore, accepts the NABP Official
Application For Transfer Of Pharmaceutic Licensure submitted by Dennis James
Farina.
THIS ORDER WAS
APPROVED BY A VOTE OF THE STATE BOARD OF PHARMACY.
MOTION CARRIED.
SO ORDERED.
The motion was seconded by Mr. Kost and approved by the Board (Aye-5/Nay-3).
RES. 2002-060 Mr. Kost moved that the Board adopt the following Order in the matter of Gerald Poorbaugh, R.Ph.:
ORDER OF THE STATE BOARD OF PHARMACY
(Docket
No. D-010405-058)
In
The Matter Of:
GERALD R. POORBAUGH, R.Ph.
445
Royal Oak Circle
Sebring,
Ohio 44672
(R.Ph. No. 03-1-08325)
INTRODUCTION
THE MATTER OF GERALD R.
POORBAUGH CAME FOR HEARING ON OCTOBER 3, 2001, BEFORE THE FOLLOWING MEMBERS OF
THE BOARD: ANN D. ABELE, R.Ph. (presiding); DIANE C. ADELMAN, R.Ph.; GREGORY
BRAYLOCK, R.Ph.; SUZANNE R. EASTMAN, R.Ph.; ROBERT P. GIACALONE, R.Ph.;
LAWRENCE J. KOST, R.Ph.; NATHAN S. LIPSYC, R.Ph.; DOROTHY S. TEATER, PUBLIC
MEMBER; AND JAMES E. TURNER, R.Ph.
GERALD R. POORBAUGH WAS NOT REPRESENTED BY COUNSEL
AND THE STATE OF OHIO WAS REPRESENTED BY SALLY ANN STEUK, ASSISTANT ATTORNEY
GENERAL.
SUMMARY
OF EVIDENCE
(A) Testimony
State's Witnesses:
(1) George Pavlich, Ohio State Board of Pharmacy
(2) Mark Keeley, R.Ph., Ohio State Board of Pharmacy
Respondent's Witnesses:
(1) Gerald R. Poorbaugh, R.Ph., Respondent
(2) Raymond Poorbaugh, R.Ph.
(B) Exhibits
State's Exhibits:
(1) Exhibit 1--Copy of four-page Notice of Opportunity for Hearing letter
dated April 5, 2001.
(2) Exhibit 1A--Hearing Request letter from Gerald R. Poorbaugh
dated April 26, 2000.
(3) Exhibit 1B--Copy of Hearing Schedule letter dated May 1, 2001.
(4) Exhibit 1C--Copy of Ohio Pharmacist Computer Record of Gerald
R. Poorbaugh.
(5) Exhibit 2--Copy of six-page Order of the State Board of
Pharmacy in the matter of Gerald R. Poorbaugh, R.Ph., Docket No. D-990914-020,
effective December 16, 1999.
(6) Exhibit 3--Copy of six-page Order of the State Board of
Pharmacy in the matter of Gromoll Drug Store, Docket No. D-990914-021,
effective December 16, 1999.
(7) Exhibit 3A--Copy of four-page Judgment Entry of Conviction, State
of Ohio vs. Gerald Poorbaugh, R.Ph., Case No. 99CRB149, Mahoning County
Court District No. 3 dated June 1, 1999.
(8) Exhibit 4--Statement of Eva Jacobson, R.N. notarized July 18,
2000.
(9) Exhibit 5--Statement of Bridget Patton, R.N. notarized July 18,
2000.
(10) Exhibit 6--Copy of Gromoll Drug Store Pharmacy Error report re
Mil Booth for Prescription No. 8015397 dated December 2, 1999, with attached
copy of Physician Orders for Mildred Booth dated November 29, 1999, and Gromoll
Drug Inc. Medical Expenses report for Mildred Booth covering December 1, 1999
to December 5, 1999.
(11) Exhibit 7--Copy of eleven-page Dangerous Drug Distributor
Inspection Report of Gromoll Drug Store dated August 15, 2000; Copy of seven
pages in response to inspection report of August 15, 2000, not dated.
(12) Exhibit 8--Seven-page Statement of Gerald R. Poorbaugh notarized
August 15, 2000.
(13) Exhibit 9--Four-page Error in Dispensing Report re Gerald
Poorbaugh, Case No. 00-1752, dated August 17, 2000.
(14) Exhibit 10--Copy of Medication Incident Report re Howard Wiant
dated December 14, 1999, with attached copy of Physician Orders for Howard
Wiant dated from October 13, 1999 to November 10, 1999, copy of Physician
Orders for Howard Wiant dated from August 17, 1999 to October 9, 1999, and
Gromoll Drug Inc. Medical Expenses report for Howard Wiant covering December 7,
1999 to December 12, 1999.
(15) Exhibit 11--Copy of Medication Incident Report re W. Abrams dated
December 27, 1999, with attached copy of Grandall Medical Center Fax Memo to
Dr. Vrable/Dr. Cohen dated December 27, 1999, copy of Grandall Medical Center
Fax Memo to Gromoll Drug Store dated December 27, 1999, copy of Physician
Orders for Walter Abrams dated from December 21, 1999 to December 29, 1999, and
Gromoll Drug Inc. Medical Expenses report re Walter Abrams covering December
23, 1999 to December 28, 1999.
(16) Exhibit 12--Copy of Medication Incident Report re Rose Brown
dated March 20, 2000, with attached copy of Physician Orders for Rose Brown
dated from February 15, 2000 to March 19, 2000, and Gromoll Drug Inc. Medical
Expenses report re Rose Brown covering March 18, 2000 to March 23, 2000.
(17) Exhibit 13--Copy of Medication Incident Report re Helen Murphy
dated March 15, 2000, with attached copy of Physician Orders for Helen Murphy
dated from March 13, 2000 to March 15, 2000, and Gromoll Drug Inc. Medical
Expenses report re Helen Murphy covering March 12, 2000 to March 18, 2000.
(18) Exhibit 14--Two-page Statement of Margaret McIlvaine notarized
July 18, 2000.
(19) Exhibit 15--Prescription No. 6292082 for Margaret McIlvain dated July 10, 2000, and copy of Gromoll
Drug Inc. Medical Expenses report re Margaret McIlvain covering July 5, 2000 to
July 15, 2000.
(20) Exhibit 16--Gromoll Drug Store prescription label for
Prescription No. 4052638 dated January 11, 2000, and July 12, 2000.
Respondent's Exhibits:
(1) None
FINDINGS
OF FACT
After having heard the testimony, observed the
demeanor of the witnesses, considered the evidence, and weighed the credibility
of each, the State Board of Pharmacy finds the following to be fact:
(1) Records of the State Board of Pharmacy indicate that Gerald R.
Poorbaugh was originally licensed by the State of Ohio on March 2, 1965,
pursuant to examination, and is currently licensed to practice pharmacy in the
state of Ohio. Records further reflect
that Gerald R. Poorbaugh is the Responsible Pharmacist at Gromoll Drug Store,
Inc. pursuant to Sections 4729.27 and 4729.55 of the Ohio Revised Code and Rule
4729-5-11 of the Ohio Administrative Code and that Gerald R. Poorbaugh was
previously disciplined by the Board, having been placed on probation through
December 16, 2001.
(2) Gerald R. Poorbaugh did, on or about December 2, 1999, misbrand
a drug and/or sell a misbranded drug, to wit: when presented with prescription
number 8015397, written for Dulcolax suppository 10mg, Gerald R. Poorbaugh
dispensed Biscodyl tablets with directions as "remove from foil and insert
one rectally." Such conduct is in
violation of Section 3715.52 of the Ohio Revised Code..
(3) Gerald R. Poorbaugh did, on or about December 10, 1999,
misbrand a drug and/or sell a misbranded drug, to wit: when presented with
prescription number 6282310, written for Remeron 30mg, Gerald R. Poorbaugh
dispensed Remeron 15mg. Such conduct is
in violation of Section 3715.52 of the Ohio Revised Code.
(4) Gerald R. Poorbaugh did, on or about December 24, 1999,
misbrand a drug and/or sell a misbranded drug, to wit: when presented with
prescription number 6282960, written for Prevacid 30mg, Gerald R. Poorbaugh
dispensed Prilosec 20mg, but labeled the vial as Prevacid 30mg. Such conduct is in violation of Section
3715.52 of the Ohio Revised Code.
(5) Gerald R. Poorbaugh did, on or about March 20, 2000, misbrand a
drug and/or sell a misbranded drug, to wit: when presented with prescription
number 8015797, written for Mylanta Liquid, Gerald R. Poorbaugh dispensed Milk
of Magnesia. Such conduct is in
violation of Section 3715.52 of the Ohio Revised Code.
(6) Gerald R. Poorbaugh did, on or about March 15, 2000, misbrand a
drug and/or sell a misbranded drug, to wit: when presented with prescription
number 4053147, written for Tussi-Organidin DM 5cc, Gerald R. Poorbaugh
dispensed Guiatuss AC with Codeine.
Such conduct is in violation of Section 3715.52 of the Ohio Revised
Code.
(7) Gerald R. Poorbaugh did, on or about July 10, 2000, misbrand a
drug and/or sell a misbranded drug, to wit: when presented with prescription
number 6292082, written for Atenolol 25mg, Gerald R. Poorbaugh dispensed
Atenolol 50mg. Such conduct is in
violation of Section 3715.52 of the Ohio Revised Code.
(8) Gerald R. Poorbaugh did, on or about August 14, 2000, and dates
preceding, when substituting generic equivalent drugs while dispensing pursuant
to prescriptions, fail to indicate on the label of the drug dispensed the
drug's generic name and distributor, to wit: the pharmacy's computer software,
QS-1, was unable to print the manufacturer, and Gerald R. Poorbaugh did not
manually include the information. Such
conduct is in violation of Section 4729.38(B) of the Ohio Revised Code and Rule
4729-5-16 of the Ohio Administrative Code.
(9) Gerald R. Poorbaugh did, on or about August 14, 2000, and dates
preceding, fail to manually initial original prescriptions when dispensing
medications when positive identification was not entered into the computerized
recordkeeping system. Such conduct is
in violation of Rule 4729-5-27(B) of the Ohio Administrative Code.
(10) Gerald R. Poorbaugh did, on or about August 14, 2000, and dates
preceding, fail to sign daily hard-copy printouts of refill data, and Gerald R.
Poorbaugh failed to maintain these printouts in chronological order. Such conduct is in violation of Rule
4729-5-28(C) of the Ohio Administrative Code.
(11) Gerald R. Poorbaugh did, on or about August 14, 2000, and dates
preceding, fail to record the full name of the prescribers' agents on original
telephone prescriptions. Such conduct
is in violation of Rule 4729-5-30(K) of the Ohio Administrative Code.
CONCLUSIONS
OF LAW
(1) Upon
consideration of the record as a whole, the State Board of Pharmacy concludes
that paragraphs (2) through (11) of the Findings of Fact constitute being
guilty of unprofessional conduct in the practice of pharmacy as provided in
Division (A)(2) of Section 4729.16 of the Ohio Revised Code.
(2) Upon consideration of the record as a whole, the State Board of
Pharmacy concludes that paragraphs (2) through (8) of the Findings of Fact
constitute being guilty of willfully violating, conspiring to violate,
attempting to violate, or aiding and abetting the violation of provisions of
Sections 3715.52 to 3715.72 or Chapter 4729. of the Revised Code as provided in
Division (A)(5) of Section 4729.16 of the Ohio Revised Code.
ACTION
OF THE BOARD
Pursuant to Section 4729.16
of the Ohio Revised Code, and on the basis of the Findings of Fact and Conclusions
of Law set forth above, the State Board of Pharmacy takes the following actions
in the matter of Gerald R. Poorbaugh:
(A) The State Board of Pharmacy hereby suspends
indefinitely the pharmacist identification card, No. 03-1-08325, held by Gerald
R. Poorbaugh effective as of the date of the mailing of this Order.
(1) Gerald R. Poorbaugh, pursuant to Rule 4729-9-01(F) of the Ohio
Administrative Code, may not be employed by or work in a facility licensed by
the State Board of Pharmacy to possess or distribute dangerous drugs during
such period of suspension.
(2) Gerald R. Poorbaugh, pursuant to Section 4729.16(B) of the Ohio
Revised Code, must return the identification card and license (wall
certificate) to the office of the State Board of Pharmacy within ten days after
receipt of this Order unless the Board office is already in possession of
both. The identification card and wall
certificate should be sent by certified mail, return receipt requested.
(B) Further, the State Board of Pharmacy will
suspend the suspension imposed above provided that Gerald R. Poorbaugh meets
the following conditions:
(1) Gerald R. Poorbaugh must take and pass, within ninety days from
the effective date of this Order, the Multistate Pharmacy Jurisprudence Examination,
or an equivalent examination approved by the Board. If Mr. Poorbaugh does not pass the examination within the
ninety-day period, his license will remain suspended until this condition has
been achieved.
(2) Gerald R. Poorbaugh must submit a plan of
corrective action to the Board within thirty days from the effective date of
this Order. An inspection will be
performed by the Board after ninety days to determine compliance with this
Order. If the inspection determines
non-compliance with this condition, Gerald R. Poorbaugh must appear before the
State Board of Pharmacy.
(C) The State Board of Pharmacy hereby extends the probation time
for Gerald R. Poorbaugh until December 16, 2002.
Gerald R. Poorbaugh is hereby advised that the Board
may at any time revoke probation for cause, modify the conditions of probation,
and reduce or extend the period of probation.
At any time during this period of probation, the Board may revoke
probation for a violation occurring during the probation period.
THIS ORDER WAS
APPROVED BY A VOTE OF THE STATE BOARD OF PHARMACY.
MOTION CARRIED.
SO ORDERED.
The motion was seconded by Ms. Eastman and approved by the Board (Aye-7/Nay-1).
5:16 p.m.
RES. 2002-061 After discussion, Mr. Lipsyc moved that the electronic prescription transmission system of Health Probe be considered approvable pending final inspection. The motion was seconded by Mrs. Adelman and approved by the Board (Aye-8/Nay-0).
5:17 p.m.
Mrs. Teater moved that the Board receive Per Diem as follows:
PER DIEM |
10/1 |
10/2 |
10/3 |
Total |
Abele |
1 |
1 |
1 |
3 |
Adelman |
- |
1 |
1 |
2 |
Braylock |
1 |
1 |
1 |
3 |
Eastman |
1 |
1 |
1 |
3 |
Giacalone |
1 |
1 |
1 |
3 |
Lipsyc |
1 |
1 |
1 |
3 |
Kost |
1 |
1 |
1 |
3 |
Teater |
1 |
1 |
1 |
3 |
Turner |
1 |
1 |
1 |
3 |
The motion was seconded by Mrs. Adelman and approved by the Board (Aye-8/Nay-0).
5:18 p.m.
Mrs. Adelman moved that the meeting be adjourned. The motion was seconded by Mr. Lipsyc and approved (Aye-8/Nay-0).
THE BOARD APPROVED THESE MINUTES ON
NOVEMBER 6, 2001. |