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.

 

 

 

Minutes Of The Meeting

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.

 

 

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.:

 

(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.

 

(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.

 

 

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.:

 

(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.

 

(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.

 

(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.

 

(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.

 

(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.

 

 

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.:

 

(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.

 

 

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.:

 

(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.

 

(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.

 

(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.

 

(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.

 

(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.

 

 

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:

 

(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

 

(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.

 

(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.

 

(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.

 

 

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.:

 

(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

 

(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.

 

(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.

 

(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.

 

 

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.:

 

(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.

 

 

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.:

 

(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.

 

(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.

 

 

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.:

 

(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

 

(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.

 

(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.

 

(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.

 

 

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.