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

January 7, 8, 9, 2002

 

MONDAY, JANUARY 7, 2002

 

  8:10 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); Diane C. Adelman, R.Ph. (Vice-President); Gregory Braylock, R.Ph.; Suzanne R. Eastman, R.Ph.; Lawrence J. Kost, R.Ph.; Nathan S. Lipsyc, R.Ph.; 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.

 

The members began a discussion of the proposed rules that were subject to the public hearing during the November, 2001 meeting.

  8:17 a.m.

Mr. Giacalone arrived and joined the meeting in progress.

 

RES. 2002-097  After discussion, Mr. Turner moved that the following rules be approved for final filing with an effective date of February 1, 2002:

 

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 advertising placing such notice in the register of Ohio.  The board may also advertise 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.

 

(2)(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 prescription. (Replaced by new 4729-5-30)

 

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 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 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.

 

(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.

 

The motion was seconded by Mr. Kost and approved by the Board (Aye-7/Nay-0).

 

RES. 2002-098  Mr. Keeley presented a list of potential members for a subcommittee to propose rules pursuant to S.B. 117 (Medical Gases).  After discussion, Mr. Turner moved that the following individuals be appointed to the subcommittee:

 

ROBERT YEOMAN/BOC Gases-VP Regulatory Affairs/CGA member

MINDY EBERHART/American Home Patient/Corp. Dir. of Regulatory Compliance

RICK HENDERSON/DeLille Oxygen Co.-Compliance Mgr./AGA member/Welding Supply Assn.

JACK POUNDS/Ohio Chemistry Technology Council-President

CHRIS ELSNER/Ohio Chemistry Technology Council-Vice President

JOE WRAY/BPSI-President/R.T.

KAM YURICICH/Exec. Director-Ohio Association of Medical Equipment Services

BARB MORGAN/Director of Clinical Services-Ohio Health Care Association

MARC MAYS/Director of Respiratory Therapy @ OSU-Ohio Hospital Association

GREG BRAYLOCK-Board Member

SUE EASTMAN-Board Member

 

The motion was seconded by Mrs. Adelman and approved by the Board (Aye-7/Nay-0).

 

RES. 2002-099  Mr. Winsley presented a request for an exemption to OAC Rule 4729-5-10 (Pick-up station) from Ken Speidel, R.Ph. so that patient-specific prescriptions for drug products that have been compounded by Ritzman Compounding Pharmacy (02-1129600) can be delivered directly to the other licensed Ritzman pharmacies.  Ms. Eastman moved that the Board approve this request due to the need for involvement by a health care professional in the patient’s drug therapy [Rule 4729-5-10(B)(5)(b)].  The motion was seconded by Mr. Braylock and approved by the Board (Aye-7/Nay-0).

 

RES. 2002-100  Mr. Benedict then presented a request from Concordia Care, Cleveland Heights (application pending) for an exemption to Rule 4729-5-10 (Pick-up station) so that patient-specific prescriptions for clients of the Adult Day Health Center can be delivered directly to Concordia Care.  After discussion, Mrs. Adelman moved that the Board approve this request due to the need for involvement by a health care professional in the patient’s drug therapy [Rule 4729-5-10(B)(5)(b)].  The motion was seconded by Ms. Eastman and approved by the Board (Aye-7/Nay-0).

 

RES. 2002-101  The Board next discussed a request from Medic Drug for an exemption to Rule 4729-5-10 (Pick-up station) so that patient-specific prescriptions prepared in patient-compliance packaging could be filled at one central Medic location and delivered to the patient’s usual Medic Pharmacy.  After discussion, Mr. Turner moved that the Board approve the request due to the need for involvement by a health care professional in the patient’s drug therapy [4729-5-10(B)(5)(b)].  The motion was seconded by Mrs. Adelman and approved by the Board (Aye-6/Nay-0/Abstain-1[Lipsyc]).

 

A request for an exemption to Rule 4729-5-10 (Pick-up station) received from the Columbus Neighborhood Health Center, Inc. was tabled pending further investigation by Board staff.

 

A request for an exemption to Rule 4729-5-10 (Pick-up station) received from the MedCentral Health System was also tabled pending further investigation by Board staff.

 

RES. 2002-102  A request for a continuance of an exemption to Rule 4729-5-11 (Responsible pharmacist) was received from Woodrow Weinstein, R.Ph. for the following locations:

 

Elmwood Place Pharmacy (02-0149650)

Elmwood Institutional Pharmacy (02-0917250)

 

After discussion, Mrs. Adelman moved that the Board extend the exemption for a period of one year.  The motion was seconded by Ms. Eastman and approved by the Board (Aye-7/Nay-0).

 

RES. 2002-103  The Board next considered a request from Carol Perry, R.Ph. for an exemption to Rule 4729-5-11 (Responsible pharmacist) for the following locations:

 

Camden Village Pharmacy (02-187400)

The Compounding Lab (application pending)

 

After discussion, Mr. Kost moved that the Board approve the exemption for a period of one year.  The motion was seconded by Mrs. Adelman and approved by the Board (Aye-7/Nay-0).

 

Ms. Abele and Mr. Kost reported that neither the Nursing Board Formulary Committee nor the Committee on Prescriptive Governance had met.

 

Mr. Benedict reported on the last meeting of the Medical Board Prescribing Committee.

 

Mr. Keeley discussed his legislative report with the Board.  There were no items requir­ing official action by the Board.

 

RES. 2002-104  Mr. Rowland announced to the Board that the following settlement agreements in the matters of Fay Christine Grant-Young, Drug Emporium #32, and Lo-Med Prescription Services had been signed by all parties and were now effective:

 

SETTLEMENT AGREEMENT WITH THE STATE BOARD OF PHARMACY

(Docket No. D-010313-046)

 

In The Matter Of:

 

Fay Christine Grant-Young, R.Ph.

5600 Big Timber Court

Gahanna, Ohio 43230

(R.Ph. No. 03-3-20190)

 

This Settlement Agreement is entered into by and between Fay Christine Grant-Young, 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.

 

Fay Christine Grant-Young, R.Ph. voluntarily enters into this Agreement being fully informed of her rights afforded under Chapter 119. of the Ohio Revised Code, including the right to representation by counsel, the right to a formal adjudication hearing on the issues contained herein, and the right to appeal.  Fay Christine Grant-Young, R.Ph. acknowledges that by entering into this agreement she has waived her rights to a formal hearing under Chapter 119. of the Revised Code.

 

Whereas, the Board 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 enforce a monetary penalty on the license holder for violation of any of the enumerated grounds therein.

 

Whereas, Fay Christine Grant-Young, R.Ph. is licensed to practice pharmacy in the State of Ohio.

 

Whereas, on or about March 13, 2001, pursuant to Chapter 119. of the Ohio Revised Code, Fay Christine Grant-Young, R.Ph. was notified of the allegations or charges against her, her right to a hearing, her rights in such hearing, and her right to submit contentions in writing.  Further, a hearing was scheduled by the Board.  The Notice of Opportunity for Hearing contains the following allegations or charges:

 

(A)     Records of the Board of Pharmacy indicate that you were originally licensed in the State of Ohio on March 3, 1994, pursuant to examination, and are currently licensed to practice pharmacy in the State of Ohio.

 

(B)     You did, on or about June 15, 2000, fail to offer or otherwise perform patient counseling, to wit: when dispensing medication to a patient pursuant to prescription number 6703909, you failed to offer patient counseling, and you did not counsel the patient.  The patient was dispensed Amoxicillin, even though he had an allergy to penicillin products; but since you did not counsel him as to the medication, he ingested it and immediately had an allergic reaction, necessitating a call to 9-1-1 for transport to a hospital.  Such conduct is in violation of Rule 4729-5-22 of the Ohio Administrative Code, and if proven constitutes being guilty of unprofessional conduct in the practice of pharmacy within the meaning of Section 4729.16 of the Ohio Revised Code.

 

Wherefore, the parties, in consideration of the mutual covenants and promises contained herein, and in lieu of any further formal proceedings at this time, and intending to be bound by said covenants, agree as follows:

 

(1)     Fay Christine Grant-Young, R.Ph., disagrees with the above charges and without admitting to any violations alleged in the State Board of Pharmacy Notice of Opportunity for Hearing dated March 13, 2001, agrees to research and prepare a written paper on the signs and symptoms of penicillin allergies and proper policies and procedures for pharmacists to follow when suspected penicillin allergy is identified.

 

(2)     Fay Christine Grant-Young, R.Ph. will present her research paper to the College of Pharmacy, Pharmacy D class, and to other Kroger pharmacists as part of a C.E. program, both to be presented to, and approved by, the State Board of Pharmacy within 90 days of this agreement and prior to its use.

 

(3)     Fay Christine Grant-Young, R.Ph.  admits and acknowledges that she is not a “prevailing eligible party” for purposes of Revised Code Sections 119.092 and 2335.39.  Further Fay Christine Grant-Young, R.Ph. waives any rights she may have under Revised Code Sections 119.09 and 2335.39.

 

(4)     Fay Christine Grant-Young, R.Ph., with intention of binding herself and her successors in interest and assigns, hereby releases, and holds harmless from liability and forever discharges the State of Ohio, the Board, the Ohio Attorney General, and any and all of their present and former members, officers, attorneys, agents and employees, personally and in their official capacities, from any and all claims, demands, causes of actions, judgments, or executions that Fay Christine Grant-Young, R.Ph. ever had, or now has or may have, known or unknown, or that anyone claiming through or under her may have or claims to have, created by or arising out of the allegations or charges filed by the Board against Fay Christine Grant-Young, R.Ph., set forth in the Notice of Opportunity for Hearing.

 

(5)     Fay Christine Grant-Young, R.Ph. acknowledges that she 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.

 

(6)     This Agreement embodies the entire agreement between and of the parties.  There are no express or implied promises, guarantees, terms, covenants, con­ditions, or obligations other than those contained herein; and this Agreement supersedes all previous communications, representations or agreements, either verbal or written, between the parties.

 

(7)     The parties hereto acknowledge that this 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.

 

 

 

SETTLEMENT AGREEMENT WITH THE STATE BOARD OF PHARMACY

(Docket No. 010615-072)

 

In the Matter of:

 

DRUG EMPORIUM #32

c/o JASON E. BOCKIS, R.Ph.

379 STONE RIDGE LANE

GAHANNA, OHIO 43230

(Terminal Distributor No. 02-0873050)

 

This Settlement Agreement is entered into by and between DRUG EMPORIUM #32 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.

 

DRUG EMPORIUM #32 ENTERS INTO THIS AGREEMENT BEING FULLY INFORMED OF ITS RIGHTS AFFORDED UNDER CHAPTER 119. OF THE OHIO REVISED CODE, INCLUDING THE RIGHT TO REPRESENTATION BY COUNSEL, THE RIGHT TO A FORMAL ADJUDICATION HEARING ON THE ISSUES CONTAINED HEREIN.

 

Whereas, the State Board of Pharmacy is empowered by Section 4729.57 of the Ohio Revised Code to suspend, revoke, refuse to renew any license issued to a terminal distributor of dangerous drugs pursuant to section 4729.54 of the Revised Code, or may impose a monetary penalty on the license holder, for violation of any of the enumerated grounds of Section 4729.57 of the Ohio Revised Code.

 

WHEREAS, DRUG EMPORIUM #32 is a licensed terminal distributor of dangerous drugs in the State of Ohio.

 

WHEREAS, on or about March 12, 2001, pursuant to Chapter 119. of the Ohio Revised Code, DRUG EMPORIUM #32 was notified of the allegations or charges against it, its right to a hearing, its rights in such hearing, and its right to submit contentions in writing. Further, a hearing was scheduled by the Board.  The  Notice of Opportunity for Hearing contains the following allegations or charges:

 

(1)     Records of the Board of Pharmacy indicate that Drug Emporium #32 is licensed with the State Board of Pharmacy as a Terminal Distributor of Dangerous Drugs. Records further reflect during the relevant time periods stated herein, you were the Responsible Pharmacist pursuant to Rule 4729-5-11 of the Ohio Admini­strative Code and Sections 4729.27 and 4729.55 of the Ohio Revised Code.

 

(2)     Drug Emporium #32 did, from February 5, 2001, through February 19, 2001, fail to notify the Board of Pharmacy by telephone immediately upon discovery of a theft of dangerous drugs, to wit:  Drug Emporium personnel observed drug thefts, confirmed them with audits, but delayed until February 20, 2001, before notifying the Board of Pharmacy of the thefts.  Such conduct is in violation of Rule 4729-9-15 of the Ohio Administrative Code, and if proven constitutes violating a rule of the Board within the meaning of Section 4729.57 of the Ohio Revised Code.

 

 

Therefore, the parties, in consideration of the mutual covenants and promises contained herein, and in lieu of any further formal proceedings at this time, and intending to be bound by said covenants, agree as follows:

 

(A)     Pursuant to Section 4729.25(B), Drug Emporium #32 is hereby reprimanded for the afore­mentioned violation of rule and/or law.

 

(B)     All Ohio Drug Emporium Pharmacies will conduct a self-assessment to ensure that phar­macy personnel, in particular pharmacists in charge,  are aware of all federal and Ohio law and record keeping regulations.  The current record keeping form will be modified to reflect DEA requirements concerning loss of controlled substance and will be in compliance with Ohio regulation 4729-9-15.

 

(C)     Ohio regulation 4729-9-15 will be discussed with each pharmacist in charge and the phar­macists will be instructed on the appropriate method for board notification. Each pharmacist in charge will be instructed of board notification upon strong suspicion or confirmation of any loss of dangerous drugs.

 

DRUG EMPORIUM #32 acknowledges that it 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.

 

 

 

SETTLEMENT AGREEMENT WITH THE STATE BOARD OF PHARMACY

(Docket No. 010713-003)

 

In the Matter of:

 

LO-MED PRESCRIPTION SERVICES, INC.

c/o Gregory S. Oswald, R.Ph.

1360 Reimer Road

Wadsworth, Ohio 44281

(Terminal Distributor No. 02-0359250)

 

This Settlement Agreement is entered into by and between LO-MED PRESCRIPTION SERVICES, INC. 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.

 

LO-MED PRESCRIPTION SERVICES, INC. ENTERS INTO THIS AGREEMENT BEING FULLY INFORMED OF ITS RIGHTS AFFORDED UNDER CHAPTER 119. OF THE OHIO REVISED CODE, INCLUDING THE RIGHT TO REPRESENTATION BY COUNSEL, THE RIGHT TO A FORMAL ADJUDICATION HEARING ON THE ISSUES CONTAINED HEREIN.

 

Whereas, the State Board of Pharmacy is empowered by Section 4729.57 of the Ohio Revised Code to suspend, revoke, refuse to renew any license issued to a terminal distributor of dangerous drugs pursuant to section 4729.54 of the Revised Code, or may impose a monetary penalty on the license holder, for violation of any of the enumerated grounds of Section 4729.57 of the Ohio Revised Code.

 

WHEREAS, Lo-Med Prescription Services, Inc. is a licensed terminal distributor of danger­ous drugs in the State of Ohio.

 

WHEREAS, on or about July 13, 2001, pursuant to Chapter 119. of the Ohio Revised Code, Lo-Med Prescription Services, Inc. was notified of the allegations or charges against it, its right to a hearing, its rights in such hearing, and its right to submit contentions in writing. Further, a hearing was scheduled by the Board.  The Notice of Opportunity for Hearing contains the following allegations or charges:

 

(1)     Records of the Board of Pharmacy indicate that Lo-Med Prescription Services, Inc. is licensed with the State Board of Pharmacy as a Terminal Distributor of Dangerous Drugs and Gregory S. Oswald is the Responsible Pharmacist pursuant to Rule 4729-5-11 of the Ohio Administrative Code and Sections 4729.27 and 4729.55 of the Ohio Revised Code.

 

(2)     Lo-Med Prescription Services, Inc., did, on or about October 26, 2000, fail to perform prospective drug utilization review, to wit: when dispensing medica­tion to a patient pursuant to prescription number R2360709, pharmacists failed to review the original prescription and/or refill information for drug-allergy interactions and/or drug-drug interactions.  The physician had ordered Ultram 50mg (patient had been taking Zoloft); during the computer entry, the technician was alerted to an allergy problem, and after an override was directed by the pharmacist, the technician was alerted to a drug-drug interaction warning.  The technician again sent the order to the pharmacist, and another override was entered.  The order does not indicate that a pharmacist author­ized any additional overrides.  Lo-Med Prescription Services, Inc. had been given a written warning for deficiencies in drug utilization review by a Board Compli­ance Specialist on July 3, 2000.  Such conduct is in violation of Rule 4729-5-20 of the Ohio Administrative Code, and Rule 4729-5-01(N) as it relates to Rule 4729-5-20 of the Ohio Administrative Code, and if proven constitutes violating a rule of the Board within the meaning of Section 4729.57 of the Ohio Revised Code.

 

(3)     Lo-Med Prescription Services, Inc., did, on or about May 16, 2000, fail to per­form pro­spective drug utilization review, to wit: when dispensing medication to a patient pursuant to prescription number 2068407, “Diflucan”, a technician entered the prescription information into the computer, entered an override when alerted to the Coumadin, and Diflucan drug interaction, and pharmacists failed to review the original prescription and/or refill information for the drug-drug interaction.  The prescription was filled and the patient suffered serious physical harm.  Such conduct is in violation of Rule 4729-5-20 of the Ohio Administrative Code, and Rule 4729-5-01(N) as it relates to Rule 4729-5-20 of the Ohio Administrative Code, and if proven constitutes violating a rule of the Board within the meaning of Section 4729.57 of the Ohio Revised Code.

 

Therefore, the parties, in consideration of the mutual covenants and promises contained herein, and in lieu of any further formal proceedings at this time, and intending to be bound by said covenants, agree as follows:

 

(A)     Lo-Med Prescription Services, Inc. will institute a Medication Intervention Policy which requires that First Data Bank will update all interactions and allergies in the computer.  All information will be printed by data entry and addressed promptly by the clinical pharmacist.

 

(B)     The pharmacist will address all interactions regardless of severity.

 

(C)     Data entry will provide the pharmacist with a copy of the order with the infor­mation attached.  Data entry will attach the interaction, allergy, and duplicate therapy to the clarification form.

 

(D)     The pharmacist will use professional judgement on the intervention required for each situation.

 

(E)      All interactions, allergies, and duplicate therapies will be addressed by a phar­macist and will include detailed documentation attached to the actual order, including the physi­cian/nurse’s full name, date, time, intervention, and pharma­cist initials.  Documentation is required even if no intervention is necessary.

 

(F)     The physician order clarification form will be faxed or sent via tote to appro­priate nursing facility for their documentation and appropriate signatures if needed.

 

(G)     The intervention report along with the physician order clarification form will be attached to the pharmacy copy of the medication orders for completion of clinical evaluation and subsequent filing.

 

(H)     No order will be processed prior to having the involved pharmacist’s verifying interven­tion, signature, and date.

 

(I)      A question and answer routine will be performed and results will be reviewed to ensure that all procedures are followed for medication orders requiring inter­vention.

 

  9:34 a.m.

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 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 Mr. Lipsyc and a roll call vote was conducted by President Abele as follows: Adelman-Yes, Braylock-Yes, Eastman-Yes, Giacalone-Yes, Lipsyc-Yes, Kost-Yes, and Turner-Yes.

10:25 a.m.

RES. 2002-105  The Executive Session ended and the meeting was opened to the public.  Ms. Eastman moved that the Board approve the settlement offer as amended by the Board in the matter of Option Care Enterprises, Inc.  The motion was seconded by Mr. Kost and approved by the Board (Aye-7/Nay-0).  The settlement will become effective upon the signature of all parties.

 

RES. 2002-106  Mr. Turner moved that the Board accept the settlement offer in the matter of Thomas Jirles, R.Ph.  The motion was seconded by Mr. Lipsyc and approved by the Board (Aye-7/Nay-0).  The settlement will become effective upon the signature of all parties.

 

RES. 2002-107  Mr. Lipsyc then moved that the Board approve the request of Darla Ellis, R.Ph. who wished to withdraw her application for reciprocity.  The motion was seconded by Mr. Giacalone and approved by the Board (Aye-7/Nay-0).

 

RES. 2002-108  Mr. Kost moved that the Board deny the request for reconsideration of its Order in the matter of Derek Duckworth R.Ph. that had been submitted by Mr. Duckworth and his attorney.  The motion was seconded by Ms. Eastman and approved by the Board (Aye-7/Nay-0).

 

RES. 2002-109  Ms. Eastman moved that the Board deny the request for reconsideration of its Orders in the matters of William Ringle, R.Ph. and The Medicine Shoppe that had been submitted by Mr. Ringle’s attorney.  The motion was seconded by Mr. Kost and approved by the Board (Aye-7/Nay-0).

 

RES. 2002-110  Ms. Eastman then moved that, pursuant to Section 3719.121 of the Revised Code, the Board summarily suspend the license to practice pharmacy belonging to Mark Alan Moore, R.Ph. (03-1-19236) 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. Kost and approved by the Board (Aye-7/Nay-0).

10:40 a.m.

The Board took a brief recess.

10:58 a.m.

The Board was joined by Assistant Attorney General Sally Ann Steuk for the purpose of creating a record in accordance with Ohio Revised Code Chapters 119. and 4729. in the matter of Lawrence E. Broome, R.Ph., Wellington.

11:26 a.m.

The record in the matter of Lawrence E. Broome, R.Ph. was closed.

11:27 a.m.

Mr. Lipsyc 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. Braylock and a roll call vote was conducted by President Abele as follows: Adelman-Yes, Braylock-Yes, Eastman-Yes, Giacalone-Yes, Lipsyc-Yes, Kost-Yes, and Turner-Yes.

11:40 a.m.

RES. 2002-111  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 Lawrence E. Broome, R.Ph.:

 

(A)     Testimony

 

         State's Witnesses:

 

(1)     Mark Kabat, Ohio State Board of Pharmacy

 

         Respondent's Witnesses:

 

(1)     None

 

(B)     Exhibits

 

         State's Exhibits:

 

(1)     Exhibit 1--Copy of three-page Notice of Opportunity for Hearing letter dated September 17, 2001.

(2)     Exhibit 1A--Hearing Request letter from John S. Haynes dated October 8, 2001.

(3)     Exhibit 1B--Copy of letter to John S. Haynes from David L. Rowland dated October 15, 2001.

(4)     Exhibit 1C--Copy of Ohio Pharmacist Computer Record of Lawrence E. Broome.

(5)     Exhibit 2--Copy of eight-page Order of the State Board Of Pharmacy, Docket No. D-970107-024, of Lawrence E. Broome, R.Ph., dated July 17, 1997.

(6)     Exhibit 3--Copy of pages 490 to 499, State Board Of Pharmacy Journal No. J-861028-079,  re Lawrence E. Broome, Docket No. 6-119-1, not dated.

(7)     Exhibit 4--Copy of Ohio State Board of Pharmacy Drug Audit Accountability Sheet for Ionamin 30mg at Rite Aid #2590 dated December 28, 2000; Copy of Ionamin 30mg Flow Sheet showing dates from May 1, 1999 to September 15, 2000, not dated.

(8)     Exhibit 5--Copy of Ohio State Board of Pharmacy Drug Audit Accountability Sheet for Phentermine 15mg at Rite Aid #2590 dated December 28, 2000; Copy of Phentermine 15mg Flow Sheet showing dates from May 1, 1999 to September 15, 2000.

(9)     Exhibit 6--Copy of Ohio State Board of Pharmacy Drug Audit Accountability Sheet for Phentermine 37.5mg at Rite Aid #2590 dated December 28, 2000; Copy of Phentermine 37.5mg Flow Sheet showing dates from May 1, 1999 to September 15, 2000.

(10)   Exhibit 7--Copy of Statement of Susan Kortyna notarized October 10, 2000.

(11)   Exhibit 8--Copy of Statement of Lawrence Broome notarized September 15, 2000.

(12)   Exhibit 9--Copy of two-page Statement of Doris Walker notarized January 3, 2001.

 

         Respondent's Exhibits:

 

(1)     None

 

(1)     On September 17, 2001, Lawrence E. Broome was notified by letter of his right to a hearing, his rights in such hearing, and his right to submit any contentions in writing.

 

(2)     As demonstrated by return receipt dated September 27, 2001, Lawrence E. Broome did receive the letter of September 17, 2001, informing him of the allegations against him, and his rights.

 

(3)     By letter from John S. Haynes, Esq. dated October 8, 2001, Lawrence E. Broome has not requested a hearing in this matter.

 

(4)     Records of the State Board of Pharmacy indicate that Lawrence E. Broome was origi­nally licensed by the State of Ohio on March 23, 1964, pursuant to examination, and is currently licensed to practice pharmacy in the state of Ohio.  Records of the Board further indicate that Lawrence E. Broome was disciplined by the Board on September 24, 1986, and again on July 17, 1997.  On each occasion, Lawrence E. Broome’s license to practice pharmacy was suspended.

 

(5)     Lawrence E. Broome did, from August 8, 1999, through September 15, 2000, with purpose to deprive, knowingly obtain or exert control over dangerous drugs, the property of Rite Aid #2590, beyond the express or implied consent of the owner, to wit: Lawrence E. Broome stole the following controlled substances:

 

Drug

 

Qty.

 

% of Stock

Ionamin 30mg

 

300

 

100%

Phentermine 15mg

 

983

 

100%

Phentermine 37.5mg

 

1,085

 

80%

 

         Such conduct is in violation of Section 2913.02 of the Ohio Revised Code .

 

(6)     Lawrence E. Broome is abusing drugs or impaired physically or mentally to such a degree as to render him unfit to practice pharmacy, to wit: Lawrence E. Broome stole drugs; Lawrence E. Broome has been observed while practicing pharmacy as if he was impaired; and, Lawrence E. Broome admitted to a coworker that he has abused drugs for a long period of time and is involved in several rehabilitation groups.  Such conduct indicates that Lawrence E. Broome is addicted to or is abusing alcohol or drugs or is impaired physically or mentally to such a degree as to render him unfit to practice pharmacy within the meaning of Section 4729.16 of the Ohio Revised Code.

 

(1)     Upon consideration of the record as a whole, the State Board of Pharmacy con­cludes that paragraph (5) of the Findings of Fact constitutes being guilty of 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 (5) and (6) 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 (6) 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 him unfit to practice pharmacy as provided in Division (A)(3) of Section 4729.16 of the Ohio Revised Code.

 

(A)     On the basis of the Findings of Fact and paragraph (1) of the Conclusions of Law set forth above, the State Board of Pharmacy hereby revokes the pharmacist identifica­tion card, No. 03-1-08147, held by Lawrence E. Broome effective as of the date of the mailing of this Order.

 

(B)     On the basis of the Findings of Fact and paragraph (2) of the Conclusions of Law set forth above, the State Board of Pharmacy hereby revokes the pharmacist identifica­tion card, No. 03-1-08147, held by Lawrence E. Broome effective as of the date of the mailing of this Order.

 

(C)     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 revokes the pharmacist identifica­tion card, No. 03-1-08147, held by Lawrence E. Broome effective as of the date of the mailing of this Order.

 

 

The motion was seconded by Mr. Kost and approved by the Board (Aye-7/Nay-0).

11:45 a.m.

The Board recessed for lunch.

  1:06 p.m.

Board Member Dorothy Teater arrived and the meeting resumed with all members present.  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 Pishotti, R.Ph., Warren.  Mr. Turner recused himself from this hearing.

  3:43 p.m.

The hearing ended and the record was closed.  The Board took a brief recess.

  4:05 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 CVS/pharmacy #3131, Westlake.

  6:50 p.m.

The hearing ended and the record was closed.

  6:55 p.m.

The meeting was recessed until Tuesday, January 8, 2002.

 

 

tuesday, january 8, 2002

 

  8:45 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.; and James E. Turner, R.Ph.

 

After a discussion of the draft minutes from the December, 2001 meeting, Mrs. Adelman moved that the minutes be approved as amended.  The motion was seconded by Ms. Eastman and approved by the Board (Aye-7/Nay-0).

  9:09 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 Steven Brownsberger, R.Ph., Medina.

10:55 a.m.

The hearing ended and the record was closed.  The Board took a brief recess.

11:12 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 George L. Plataz, R.Ph., Willoughby.

11:51 a.m.

The hearing was recessed for lunch.

  1:00 p.m.

The Board convened 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.; and James E. Turner, R.Ph.

 

RES. 2002-112  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 Mr. Braylock and approved by the Board (Aye-7/Nay-0).

 

GINA MARIE BOROWICZ

ARIZONA

MICHAEL GLENNON CARR

KENTUCKY

MARGARET ANN DAVIS

GEORGIA

ALLEN I. DINES

PENNSYLVANIA

LISA KAY HENEGHAN

PENNSYLVANIA

TOBY ELLEN HORWITZ

MICHIGAN

REX A. SWORDS

NEW MEXICO

JEREMY GUY THAIN

INDIANA

TERRY HARLAN WEAVER

TEXAS

  1:23 p.m.

The Board reconvened in Room 1919 to continue the hearing in the matter of George L. Plataz, R.Ph.

  2:02 p.m.

The hearing ended and the record was closed.  The Board took a brief recess.

  2:10 p.m.

RES. 2002-113  After further information had been obtained by Board staff, the Board continued the discussion on the request from MedCentral Health System for an exemption to Rule 4729-5-10 (Pick-up station).  Ms. Eastman moved that the request be approved for the following two locations for patient-specific injectable medications only.  This approval is due to the need for involvement by a health care professional in the patient’s drug therapy [Rule 4729-5-10(B)(5)(b)]:

 

Mansfield Hospital  (02-0031050)

Center for Pain Control  (02-1290800)

 

The motion was seconded by Mr. Giacalone and approved by the Board (Aye-7/Nay-0).

 

RES. 2002-114  The Board next considered the previously tabled request from Columbus Neighborhood Health Center, Inc. for an exemption to Rule 4729-5-10 (Pick-up station).  After clarification of the request was presented by Mr. Benedict, Ms. Eastman moved that the Board approve the request for the following two locations due to the need for involvement by a health care professional in the patient’s drug therapy [Rule 4729-5-10(B)(5)(b)]:

 

Northeast Health Center, Columbus, Ohio  (02-1250000)

Med-Share Pharmacy,  Cincinnati, Ohio  (02-0257600)

 

The motion was seconded by Mr. Braylock and approved by the Board (Aye-7/Nay-0).

  2:39 p.m.

Mr. Lipsyc 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. Braylock and a roll call vote was conducted by President Abele as follows: Adelman-Yes, Braylock-Yes, Eastman-Yes, Giacalone-Yes, Lipsyc-Yes, Kost-Yes, and Turner-Yes.

  3:45 p.m.

RES. 2002-115  The Executive Session ended and the meeting was opened to the public.  Ms. Eastman moved that the Board accept the settlement offer received in the matter of Moletha Coleman, Pharmacy Intern.  The motion was seconded by Mr. Kost and approved by the Board (Aye-7/Nay-0).  The settlement will become final upon the signature of all parties.

 

RES. 2002-116  Ms. Eastman then moved that the Board refuse to accept the settlement offer issued in the matters of Kinsman Pharmacy, Donald R. Sutton, R.Ph., and Robert C. Sutton, R.Ph. that had been submitted on their behalf by their attorney.  The motion was seconded by Mr. Braylock and approved by the Board (Aye-7/Nay-0).

 

RES. 2002-117  Mrs. Adelman moved that the Board issue the following Order in the matter of George L. Plataz, R.Ph.:

 

(A)     Testimony

 

         State's Witnesses:

 

(1)     Lynn Mudra, Ohio State Board of Pharmacy

 

         Respondent's Witnesses:

 

(1)     George L. Plataz, R.Ph., Respondent

(2)     Robert Tschinkel, R.Ph.

(3)     Todd Jaros, R.Ph.

 

(B)     Exhibits

 

         State's Exhibits:

 

(1)     Exhibit 1--Copy of eight-page Summary Suspension Order/Notice of Opportunity for Hearing letter dated October 4, 2001.

(2)     Exhibit 1A--Hearing Request letter from John R. Irwin, M.D. dated October 17, 2001.

(3)     Exhibit 1B--Copy of Hearing Schedule letter dated October 22, 2001.

(4)     Exhibit 1C--Copy of eight-page Amendment/Addendum Notice letter dated October 22, 2001.

(5)     Exhibit 1D--Copy of Ohio Pharmacist Computer Record of George Leonard Plataz printed October 4, 2001.

(6)     Exhibit 2--Copy of Customer Receipt for Prescription No. N 659674 00 dated September 26, 1998.

(7)     Exhibit 3--Copy of Customer Receipt for Prescription No. N 663440 00 dated November 2, 1998.

(8)     Exhibit 4--Copy of Customer Receipt for Prescription No. N 666333 00 dated December 1, 1998.

(9)     Exhibit 5--Copy of Customer Receipt for Prescription No. N 669318 00 dated January 2, 1999.

(10)   Exhibit 6--Copy of Customer Receipt for Prescription No. N 673613 00 dated February 11, 1999.

(11)   Exhibit 7--Copy of Customer Receipt for Prescription No. N 675568 00 dated February 27, 1999.

(12)   Exhibit 8--Copy of Customer Receipt for Prescription No. N 680332 00 dated April 11, 1999.

(13)   Exhibit 9--Copy of Customer Receipt for Prescription No. N 686043 00 dated June 5, 1999.

(14)   Exhibit 10--Copy of Customer Receipt for Prescription No. N 688768 00 dated July 2, 1999.

(15)   Exhibit 11--Copy of Customer Receipt for Prescription No. N 692877 00 dated August 13, 1999.

(16)   Exhibit 12--Copy of Customer Receipt for Prescription No. N 732792 00 dated August 14, 2000.

(17)   Exhibit 13--Copy of Customer Receipt for Prescription No. N 733583 00 dated August 22, 2000.

(18)   Exhibit 14--Copy of Customer Receipt for Prescription No. N 740299 00 dated October 21, 2000.

(19)   Exhibit 15--Copy of Customer Receipt for Prescription No. N 746175 00 dated December 11, 2000.

(20)   Exhibit 16--Copy of Customer Receipt for Prescription No. N 755063 00 dated February 23, 2001.

(21)   Exhibit 17--Copy of Customer Receipt for Prescription No. N 768948 00 dated June 15, 2001.

(22)   Exhibit 18--Copy of Customer Receipt for Prescription No. N 774298 00 dated August 1, 2001.

(23)   Exhibit 19--Copy of CVS/REVCO #4316 Pharmacist’s Statement report covering September 26, 1998 to August 1, 2001, dated September 17, 2001.

(24)   Exhibit 20--Copy of Customer Receipt for Prescription No. N 675565 00 dated February 27, 1999.

(25)   Exhibit 21--Copy of Customer Receipt for Prescription No. N 686044 00 dated June 5, 1999.

(26)   Exhibit 22--Copy of Customer Receipt for Prescription No. N 694251 00 dated August 27, 1999.

(27)   Exhibit 23--Copy of Customer Receipt for Prescription No. N 741925 00 dated November 4, 2000.

(28)   Exhibit 24--Copy of Customer Receipt for Prescription No. N 746749 00 dated December 14, 2000.

(29)   Exhibit 25--Copy of Customer Receipt for Prescription No. N 751627 00 dated January 26, 2001.

(30)   Exhibit 26--Copy of Customer Receipt for Prescription No. N 756556 00 dated March 7, 2001.

(31)   Exhibit 27--Copy of Customer Receipt for Prescription No. N 770723 00 dated June 29, 2001.

(32)   Exhibit 28--Copy of Customer Receipt for Prescription No. N 774768 00 dated August 25, 2001.

(33)   Exhibit 29--Copy of Customer Receipt for Prescription No. N 777238 00 dated August 25, 2001.

(34)   Exhibit 30--Copy of eleven-page CVS/REVCO #4316 Pharmacist’s Statement report covering February 27, 1999 to September 16, 2001, dated September 17, 2001.

(35)   Exhibit 31--Copy of Customer Receipt for Prescription No. N 740137 00 dated October 20, 2000.

(36)   Exhibit 32--Copy of Customer Receipt for Prescription No. N 777280 00 dated August 25, 2001.

(37)   Exhibit 33--Copy of Customer Receipt for Prescription No. N 745880 00 dated December 7, 2000.

(38)   Exhibit 34--Copy of Customer Receipt for Prescription No. N 733991 00 dated August 26, 2000.

(39)   Exhibit 35--Copy of CVS/REVCO #4316 Pharmacist’s Statement report covering October 20, 2000 to August 25, 2001, date illegible.

(40)   Exhibit 36--Copy of Customer Receipt for Prescription No. N 737728 00 dated September 28, 2000.

(41)   Exhibit 37--Copy of Customer Receipt for Prescription No. N 739603 00 dated October 16, 2000.

(42)   Exhibit 38--Copy of Customer Receipt for Prescription No. N 741130 00 dated October 30, 2000.

(43)   Exhibit 39--Copy of Customer Receipt for Prescription No. N 744962 00 dated November 30, 2000.

(44)   Exhibit 40--Copy of Customer Receipt for Prescription No. N 747885 00 dated December 26, 2000.

(45)   Exhibit 41--Copy of Customer Receipt for Prescription No. N 753371 00 dated February 9, 2001.

(46)   Exhibit 42--Copy of Customer Receipt for Prescription No. N 756660 00 dated March 7, 2001.

(47)   Exhibit 43--Copy of Customer Receipt for Prescription No. N 761940 00 dated April 18, 2001.

(48)   Exhibit 44--Copy of Customer Receipt for Prescription No. N 768393 00 dated June 11, 2001.

(49)   Exhibit 45--Copy of Customer Receipt for Prescription No. N 770390 00 dated June 27, 2001.

(50)   Exhibit 46--Copy of Customer Receipt for Prescription No. N 773918 00 dated July 29, 2001.

(51)   Exhibit 47--Copy of CVS/REVCO #4316 Pharmacist’s Statement report covering August 23, 2000 to July 29, 2001, date illegible.

(52)   Exhibit 48--Copy of Customer Receipt for Prescription No. N 733570 00 dated August 22, 2000.

(53)   Exhibit 49--Copy of Customer Receipt for Prescription No. N 738807 00 dated October 8, 2000.

(54)   Exhibit 50--Copy of Customer Receipt for Prescription No. N 741745 00 dated November 3, 2000.

(55)   Exhibit 51--Copy of Customer Receipt for Prescription No. N 744963 00 dated November 30, 2000.

(56)   Exhibit 52--Copy of Customer Receipt for Prescription No. N 749889 00 dated January 12, 2001.

(57)   Exhibit 53--Copy of Customer Receipt for Prescription No. N 755064 00 dated February 23, 2001.

(58)   Exhibit 54--Copy of Customer Receipt for Prescription No. N 762257 00 dated April 21, 2001.

(59)   Exhibit 55--Copy of Customer Receipt for Prescription No. N 769071 00 dated June 15, 2001.

(60)   Exhibit 56--Copy of Customer Receipt for Prescription No. N 770618 00 dated June 29, 2001.

(61)   Exhibit 57--Copy of Customer Receipt for Prescription No. N 774706 00 dated October 3, 2001.

(62)   Exhibit 58--Copy of CVS/REVCO #4316 Pharmacist’s Statement report covering August 22, 2000 to August 3, 2001, date illegible.

 

         Respondent's Exhibits:

 

(1)     Exhibit A--Three-page PRO Inc. Pharmacist’s Recovery Contract of George Plataz dated October 10, 2001.

(2)     Exhibits B to B4--Five pages of support group attendance records dated from September 19, 2001 to December 26, 2001.

(3)     Exhibits C to C2--Copy of three-page Cleveland Clinic Foundation Lab Results Summary of George L. Plataz dated from August 20, 2001 to April 17, 2002.

(4)     Exhibit D--Letter from Rudy Kump, M.A., CCDCIII dated November 19, 2001.

(5)     Exhibit E--Copy of letter from Rudy Kump, M.A. CCDCIII dated January 4, 2002.

(6)     Exhibit F--Copy of letter from Terry A. King, MD dated October 14, 1999.

(7)     Exhibit G--Copy of letter from Terry Alan King, MD dated March 16, 2000.

(8)     Exhibit H--Copy of letter from Robert F. Tschinkel dated January 2, 2002.

(9)     Exhibit I1--Copy of handwritten prescription for George Plataz for Revia 50mg dated November 13, 2001 with typed notes signed by George Plataz.

(10)   Exhibits I2 to I6--Copy of five pages of Quest Diagnostics drug screen reports for specimens collected from George L. Plataz on October 25, 2001, November 11, 2001, and December 16, 2001.

(11)   Exhibit J--Support group attendance record dated from December 27, 2001 to January 7, 2002.

 

(1)     Records of the State Board of Pharmacy indicate that George L. Plataz was originally licensed by the State of Ohio on February 5, 1976, pursuant to reciprocity, and that his license to practice pharmacy in the state of Ohio was summarily suspended effective October 4, 2001.

 

(2)     George L. Plataz is addicted to liquor or drugs or impaired physically or mentally to such a degree as to render him unfit to practice pharmacy, to wit: George L. Plataz admitted to a Board agent that he was addicted to narcotics; George L. Plataz admitted that he consumed for personal abuse eight Percocet daily.  Such conduct indicates that George L. Plataz falls within the ambit of Sections 3719.121(A) and (B), and 4729.16(A)(3) of the Ohio Revised Code.

 

(3)     George L. Plataz did, on or about the following dates, with purpose to deprive, knowingly obtain or exert control over dangerous drugs, the property of CVS/pharmacy #6301, beyond the express or implied consent of the owner, to wit: George L. Plataz stole the following controlled substances from his employer:

 

Drug

Schedule

Date

Quantity

 

Rx #

Dexedrine Spansules 15mg

II

09/26/98

50

 

N 659674

Dexedrine Spansules 15mg

II

11/02/98

50

 

N 663440

Dexedrine Spansules 15mg

II

12/01/98

50

 

N 666333

Dexedrine Spansules 15mg

II

01/02/99

50

 

N 669318

Dexedrine Spansules 15mg

II

02/11/99

49

 

N 673613

Dexedrine Spansules 15mg

II

02/27/99

50

 

N 675568

Dexedrine Spansules 15mg

II

04/11/99

50

 

N 680332

Dexedrine Spansules 15mg

II

06/05/99

50

 

N 686043

Dexedrine Spansules 15mg

II

07/02/99

50

 

N 688768

Dexedrine Spansules 15mg

II

08/13/99

50

 

N 692877

Dexedrine Spansules 15mg

II

08/14/00

24

 

N 732792

Dexedrine Spansules 15mg

II

08/22/00

24

 

N 733583

Dexedrine Spansules 15mg

II

10/21/00

30

 

N 740299

Dexedrine Spansules 15mg

II

12/11/00

30

 

N 746175

Dexedrine Spansules 15mg

II

02/23/01

30

 

N 755063

Dexedrine Spansules 15mg

II

06/15/01

36

 

N 768948

Dexedrine Spansules 15mg

II

08/01/01

36

 

N 774298

IC Endocet

II

08/22/00

120

 

N 733570

IC Endodan

II

02/27/99

100

 

N 675565

IC Endodan

II

06/05/99

90

 

N 686044

IC Endocet

II

08/27/99

120

 

N 694251

IC Endodan

II

10/20/00

100

 

N 740137

IC Endodan

II

11/30/00

120

 

N 744963

IC Endodan

II

12/26/00

100

 

N 747885

IC Oxycodone

II

01/12/01

120

 

N 749889

IC Endodan

II

02/23/01

100

 

N 755064

IC Endodan

II

03/07/01

100

 

N 756660

IC Endodan

II

06/29/01

120

 

N 770618

IC Endodan

II

07/29/01

120

 

N 773918

IC Endodan

II

08/03/01

120

 

N 774706

IC Endodan

II

08/25/01

120

 

N 777238

IC Oxycodone

II

10/08/00

100

 

N 738807

IC Oxycodone

II

10/16/00

120

 

N 739603

IC Oxycodone

II

11/03/00

120

 

N 741745

IC Oxycodone

II

12/14/00

120

 

N 746749

IC Oxycodone

II

04/21/01

100

 

N 762257

IC Oxycodone

II

06/29/01

120

 

N 770723

IC Oxycodone

II

08/25/01

100

 

N 777280

OxyContin 20mg

II

09/28/00

30

 

N 737728

OxyContin 20mg

II

10/30/00

30

 

N 741130

OxyContin 20mg

II

11/04/00

20

 

N 741925

OxyContin 20mg

II

11/30/00

30

 

N 744962

OxyContin 20mg

II

01/26/01

40

 

N 751627

OxyContin 20mg

II

02/09/01

60

 

N 753371

OxyContin 20mg

II

03/07/01

30

 

N 756556

OxyContin 20mg

II

06/15/01

60

 

N 769071

OxyContin 20mg

II

06/27/01

60

 

N 770390

OxyContin 20mg

II

08/05/01

60

 

N 774768

IC Endodan

II

04/18/01

120

 

N 761940

IC Endodan

II

06/11/01

120

 

N 768393

OxyContin 20mg

II

08/26/00

20

 

N 733991

OxyContin 20mg

II

12/07/00

60

 

N 745880

 

         Such conduct violates Section 2913.02 of the Ohio Revised Code.

 

(4)     George L. Plataz did, on or about the following dates, knowingly possess or use a controlled substance when not in accordance with Chapters 3719. and 4729. of the Ohio Revised Code, to wit: George L. Plataz admitted to possessing the following drugs:

 

Drug

Schedule

Date

Quantity

 

Rx #

Dexedrine Spansules 15mg

II

09/26/98

50

 

N 659674

Dexedrine Spansules 15mg

II

11/02/98

50

 

N 663440

Dexedrine Spansules 15mg

II

12/01/98

50

 

N 666333

Dexedrine Spansules 15mg

II

01/02/99

50

 

N 669318

Dexedrine Spansules 15mg

II

02/11/99

49

 

N 673613

Dexedrine Spansules 15mg

II

02/27/99

50

 

N 675568

Dexedrine Spansules 15mg

II

04/11/99

50

 

N 680332

Dexedrine Spansules 15mg

II

06/05/99

50

 

N 686043

Dexedrine Spansules 15mg

II

07/02/99

50

 

N 688768

Dexedrine Spansules 15mg

II

08/13/99

50

 

N 692877

Dexedrine Spansules 15mg

II

08/14/00

24

 

N 732792

Dexedrine Spansules 15mg

II

08/22/00

24

 

N 733583

Dexedrine Spansules 15mg

II

10/21/00

30

 

N 740299

Dexedrine Spansules 15mg

II

12/11/00

30

 

N 746175

Dexedrine Spansules 15mg

II

02/23/01

30

 

N 755063

Dexedrine Spansules 15mg

II

06/15/01

36

 

N 768948

Dexedrine Spansules 15mg

II

08/01/01

36

 

N 774298

IC Endocet

II

08/22/00

120

 

N 733570

IC Endodan

II

02/27/99

100

 

N 675565

IC Endodan

II

06/05/99

90

 

N 686044

IC Endocet

II

08/27/99

120

 

N 694251

IC Endodan

II

10/20/00

100

 

N 740137

IC Endodan

II

11/30/00

120

 

N 744963

IC Endodan

II

12/26/00

100

 

N 747885

IC Oxycodone

II

01/12/01

120

 

N 749889

IC Endodan

II

02/23/01

100

 

N 755064

IC Endodan

II

03/07/01

100

 

N 756660

IC Endodan

II

06/29/01

120

 

N 770618

IC Endodan

II

07/29/01

120

 

N 773918

IC Endodan

II

08/03/01

120

 

N 774706

IC Endodan

II

08/25/01

120

 

N 777238

IC Oxycodone

II

10/08/00

100

 

N 738807

IC Oxycodone

II

10/16/00

120

 

N 739603

IC Oxycodone

II

11/03/00

120

 

N 741745

IC Oxycodone

II

12/14/00

120

 

N 746749

IC Oxycodone

II

04/21/01

100

 

N 762257

IC Oxycodone

II

06/29/01

120

 

N 770723

IC Oxycodone

II

08/25/01

100

 

N 777280

OxyContin 20mg

II

09/28/00

30

 

N 737728

OxyContin 20mg

II

10/30/00

30

 

N 741130

OxyContin 20mg

II

11/04/00

20

 

N 741925

OxyContin 20mg

II

11/30/00

30

 

N 744962

OxyContin 20mg

II

01/26/01

40

 

N 751627

OxyContin 20mg

II

02/09/01

60

 

N 753371

OxyContin 20 mg

II

03/07/01

30

 

N 756556

OxyContin 20mg

II

06/15/01

60

 

N 769071

OxyContin 20mg

II

06/27/01

60

 

N 770390

OxyContin 20mg

II

08/05/01

60

 

N 774768

IC Endodan

II

04/18/01

120

 

N 761940

IC Endodan

II

06/11/01

120

 

N 768393

OxyContin 20mg

II

08/26/00

20

 

N 733991

OxyContin 20mg

II

12/07/00

60

 

N 745880

 

         Such conduct violates Section 2925.11 of the Ohio Revised Code.

 

(5)     George L. Plataz did, on or about the following dates, intentionally make, utter, or sell, or knowingly possess false or forged prescriptions, to wit: when stealing drugs and/or trafficking in drugs, George L. Plataz created the following prescriptions to cover for his theft of drugs:

 

Drug

Schedule

Date

Quantity

 

Rx #

Dexedrine Spansules 15mg

II

09/26/98

50

 

N 659674

Dexedrine Spansules 15mg

II

11/02/98

50

 

N 663440

Dexedrine Spansules 15mg

II

12/01/98

50

 

N 666333

Dexedrine Spansules 15mg

II

01/02/99

50

 

N 669318

Dexedrine Spansules 15mg

II

02/11/99

49

 

N 673613

IC Endodan

II

02/27/99

100

 

N 675565

Dexedrine Spansules 15mg

II

02/27/99

50

 

N 675568

Dexedrine Spansules 15mg

II

04/11/99

50

 

N 680332

Dexedrine Spansules 15mg

II

06/05/99

50

 

N 686043

IC Endodan

II

06/05/99

90

 

N 686044

Dexedrine Spansules 15mg

II

07/02/99

50

 

N 688768

Dexedrine Spansules 15mg

II

08/13/99

50

 

N 692877

IC Endocet

II

08/27/99

120

 

N 694251

Dexedrine Spansules 15mg

II

08/14/00

24

 

N 732792

IC Endocet

II

08/22/00

120

 

N 733570

Dexedrine Spansules 15mg

II

08/22/00

24

 

N 733583

OxyContin 20mg

II

09/28/00

30

 

N 737728

IC Oxycodone

II

10/08/00

100

 

N 738807

IC Oxycodone

II

10/16/00

120

 

N 739603

IC Endodan

II

10/20/00

100

 

N 740137

Dexedrine Spansules 15mg

II

10/21/00

30

 

N 740299

OxyContin 20mg

II

10/30/00

30

 

N 741130

IC Oxycodone

II

11/03/00

120

 

N 741745

OxyContin 20mg

II

11/04/00

20

 

N 741925

OxyContin 20mg

II

11/30/00

30

 

N 744962

IC Endodan

II

11/30/00

120

 

N 744963

Dexedrine Spansules 15mg

II

12/11/00

30

 

N 746175

IC Oxycodone

II

12/14/00

120

 

N 746749

IC Endodan

II

12/26/00

100

 

N 747885

IC Oxycodone

II

01/12/01

120

 

N 749889

OxyContin 20mg

II

01/26/01

40

 

N 751627

OxyContin 20mg

II

02/09/01

60

 

N 753371

Dexedrine Spansules 15mg

II

02/23/01

30

 

N 755063

IC Endodan

II

02/23/01

100

 

N 755064

OxyContin 20mg

II

03/07/01

30

 

N 756556

IC Endodan

II

03/07/01

100

 

N 756660

IC Oxycodone

II

04/21/01

100

 

N 762257

Dexedrine Spansules 15mg

II

06/15/01

36

 

N 768948

OxyContin 20mg

II

06/15/01

60

 

N 769071

OxyContin 20mg

II

06/27/01

60

 

N 770390

IC Endodan

II

06/29/01

120

 

N 770618

IC Oxycodone

II

06/29/01

120

 

N 770723

IC Endodan

II

07/29/01

120

 

N 773918

Dexedrine Spansules 15mg

II

08/01/01

36

 

N 774298

IC Endodan

II

08/03/01

120

 

N 774706

OxyContin 20mg

II

08/05/01

60

 

N 774768

IC Endodan

II

08/25/01

120

 

N 777238

IC Oxycodone

II

08/25/01

100

 

N 777280

IC Endodan

II

04/18/01

120

 

N 761940

IC Endodan

II

06/11/01

120

 

N 768393

OxyContin 20mg

II

08/26/00

20

 

N 733991

OxyContin 20mg

II

12/07/00

60

 

N 745880

 

         Such conduct violates Section 2925.23(B) of the Ohio Revised Code.

 

(6)     George L. Plataz did, on or about the following dates, knowing he had no privilege to do so, and with purpose to defraud or knowing that he was facilitating a fraud, falsify writing, data, or record, to wit: George L. Plataz entered dispensing records in the following patients’ drug dispensing profiles when they did not receive the drugs:

 

Patient

Drug

Schedule

Date

Quantity

Rx #

A

IC Endodan

II

02/27/99

100

N 675565

A

IC Endodan

II

06/05/99

90

N 686044

A

IC Endocet

II

08/27/99

120

N 694251

A

OxyContin 20mg

II

11/04/00

20

N 741925

A

IC Oxycodone

II

12/14/00

120

N 746749

A

OxyContin 20mg

II

01/26/01

40

N 751627

A

OxyContin 20mg

II

03/07/01

30

N 756556

A

IC Oxycodone

II

06/29/01

120

N 770723

A

OxyContin 20mg

II

08/05/01

60

N 774768

A

IC Endodan

II

08/25/01

120

N 777238

B

IC Endodan

II

10/20/00

100

N 740137

B

IC Oxycodone

II

08/25/01

100

N 777280

C

OxyContin 20mg

II

09/28/00

30

N 737728

C

IC Oxycodone

II

10/16/00

120

N 739603

C

OxyContin 20mg

II

10/30/00

30

N 741130

C

OxyContin 20mg

II

11/30/00

30

N 744962

C

IC Endodan

II

12/26/00

100

N 747885

C

OxyContin 20mg

II

02/09/01

60

N 753371

C

IC Endodan

II

03/07/01

100

N 756660

C

OxyContin 20mg

II

06/27/01

60

N 770390

C

IC Endodan

II

07/29/01

120

N 773918

D

IC Endocet

II

08/22/00

120

N 733570

D

IC Oxycodone

II

10/08/00

100

N 738807

D

IC Oxycodone

II

11/03/00

120

N 741745

D

IC Endodan

II

11/30/00

120

N 744963

D

IC Oxycodone

II

01/12/01

120

N 749889

D

IC Endodan

II

02/23/01

100

N 755064

D

IC Oxycodone

II

04/21/01

100

N 762257

D

OxyContin 20mg

II

06/15/01

60

N 769071

D

IC Endodan

II

06/29/01

120

N 770618

D

IC Endodan

II

08/03/01

120

N 774706

E

Dexedrine Spansules 15mg

II

09/26/98

50

N 659674

E

Dexedrine Spansules 15mg

II

11/02/98

50

N 663440

E

Dexedrine Spansules 15mg

II

12/01/98

50

N 666333

E

Dexedrine Spansules 15mg

II

01/02/99

50

N 669318

E

Dexedrine Spansules 15mg

II

02/11/99

49

N 673613

E

Dexedrine Spansules 15mg

II

02/27/99

50

N 675568

E

Dexedrine Spansules 15mg

II

04/11/99

50

N 680332

E

Dexedrine Spansules 15mg

II

06/05/99

50

N 686043

E

Dexedrine Spansules 15mg

II

07/02/99

50

N 688768

E

Dexedrine Spansules 15mg

II

08/13/99

50

N 692877

E

Dexedrine Spansules 15mg

II

08/14/00

24

N 732792

E

Dexedrine Spansules 15mg

II

08/22/00

24

N 733583

E

Dexedrine Spansules 15mg

II

10/21/00

30

N 740299

E

Dexedrine Spansules 15mg

II

12/11/00

30

N 746175

E

Dexedrine Spansules 15mg

II

02/23/01

30

N 755063

E

Dexedrine Spansules 15mg

II

06/15/01

36

N 768948

E

Dexedrine Spansules 15mg

II

08/01/01

36

N 774298

C

IC Endodan

II

04/18/01

120

N 761940

C

IC Endodan

II

06/11/01

120

N 768393

B

OxyContin 20mg

II

08/26/00

20

N 733991

B

OxyContin 20mg

II

12/07/00

60

N 745880

 

         Such conduct violates Section 2913.42 of the Ohio Revised Code.

 

(1)     Upon consideration of the record as a whole, the State Board of Pharmacy con­cludes that paragraphs (3) through (6) of the Findings of Fact constitute being guilty of 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 (6) 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 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 (4) and (5) 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)     George L. Plataz, 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)     George L. Plataz, 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)     George L. Plataz 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)     George L. Plataz must demonstrate satisfactory proof to the Board that he is no longer addicted to or abusing drugs or impaired physically or mentally to such a degree as to render him unfit to practice pharmacy.

 

(C)     George L. Plataz 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, George L. Plataz 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-6/Nay-1).

 

RES. 2002-118  Mr. Braylock moved that the Board issue the following Order in the matter of Steven Brownsberger, R.Ph.:

 

(A)     Testimony

 

         State's Witnesses:

 

(1)      None

 

         Respondent's Witnesses:

 

(1)      Steven Brownsberger, R.Ph., Respondent

(2)      Wayne C. Miller, R.Ph.

 

(B)      Exhibits

 

         State's Exhibits:

 

(1)      Exhibit 1

 

(2)      Exhibit 1A--Copy of two-page Hearing Schedule letter dated May 29, 2001.

(3)      Exhibit 1B--Copy of Ohio Pharmacist Computer Record of Steven J. Browns­berger.

(4)      Exhibit 1C--Copy of Ohio Pharmacist File Front Sheet of Steven J. Brownsberger showing original date of registration as October 26, 1990; Copy of two-page Renewal Application For Pharmacist License No. 03-3-18617 for a license to practice pharmacy in Ohio from September 15, 1999 to September 15, 2000 by Steven J. Brownsberger dated July 21, 1999.

(5)      Exhibit 2

(6)      Exhibit 2A

(7)      Exhibit 2B--Copy of Ohio State Board of Pharmacy Release Form from Steven Brownsberger notarized October 28, 1999; Copy of two-page letter from Karl C. Meyer, MAHE, CCDC III-E dated January 6, 2000;

(8)      Exhibit 3

(9)      Exhibit 4

(10)    Exhibit 5

(11)    Exhibit 6

(12)    Exhibit 7

(13)    Exhibit 8

(14)    Exhibit 9

(15)    Exhibit 10

(16)    Exhibit 11

(17)    Exhibit 12

(18)    Exhibit 13

(19)    Exhibit 14

(20)    Exhibit 15

(21)    Exhibit 16

(22)    Exhibit 17

(23)    Exhibit 18--Copy of nine-page Order of the State Board Of Pharmacy, Docket No. D-000208-044 in the matter of Steven J. Brownsberger, R.Ph. dated July 17, 2000.

(24)    Exhibit 19

(25)    Exhibit 20

(26)    Exhibit 21

 

         Respondent's Exhibits:

 

(1)      Exhibit R1--Copy of ADDS Inc. Pharmacist Recovery Contract of Steve Browns­berger dated October 16, 2000.

(2)      Exhibit R2--Twenty pages of copies of drug screen reports for samples collected from Steven Brownsberger from November 9, 2000 to December 7, 2001.

(3)      Exhibit R3--Fifteen pages of support group attendance records of Steven Brownsberger dated from May 28, 2000 to January 3, 2002.

(4)      Exhibit R4—

         Tom Fisher dated January 4, 2002; Robert F. Wood, M.D., not dated; Bobbijean E. Wood, M.D., not dated; Kathleen M. Kavlick, R.N. dated January 2, 2002;

         John Brownsberger dated January 4, 2002; Michael Hill dated January 5, 2002; Dale Anthony Foy dated January 1, 2001; Jennifer K. Pasadyn, LSW dated January 2, 2002; Ken D. Kirstein, RN dated January 3, 2002; Diana B. Young, LISW, LPCC, CCDC III-E dated December 10, 2001;

         Terry Daley, MS, CCDCIII, SWA dated April 26, 2001; and Beth A. Humbert dated January 3, 2002.

(5)      Exhibit R5--Twenty pages of copies of Continuing Pharmacy Education Certifi­cates dated from October 11, 1997 to January 3, 2002.

(6)      Exhibit R6--Copy of newspaper article titled "Woman With Warrants Arrested", The Plain Dealer, October 17, 2001; Copy of newspaper article titled "Driver Flees Police, Causes Crash on Broadway, newspaper not identified and not dated; Copy of four-page Medina City Police Department Ohio Traffic Crash Report No. 01-032789 of Rebecca S. Nelson and Steven J. Brownsberger dated October 15, 2001; and copy of two pages of CCC Information Services, Inc. Nationwide Insurance Market Valuation Report of Steven Brownsberger, Report Reference No. 28275957, dated October 16, 2001.

 

(A)     Provides documentation of one year of continuous compliance with the Board's July 17, 2000 Order (e.g.-copies of all monthly drug and alcohol screen reports, support group meeting attendance records for at least three times per week, treatment program reports, etc.);

 

(B)      Demonstrates satisfactory proof that he is no longer addicted to or abusing liquor or drugs or impaired physically or mentally to such a degree as to render him unfit to practice pharmacy;

 

(C)     

 

 

The motion was seconded by Mrs. Adelman and approved by the Board (Aye-7/Nay-0).

  4:08 p.m.

The meeting was recessed until Wednesday, January 9, 2002.

 

 

wednesday, january 9, 2002

 

  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); Robert P. Giacalone, R.Ph.; Lawrence J. Kost, R.Ph.; Nathan S. Lipsyc, R.Ph.; and James E. Turner, R.Ph.

  8:04 a.m.

Mr. Giacalone moved that the Board go into Executive Session for the purpose of considering the appointment, employment, dismissal, discipline, promotion, demotion, or compensation of a public employee or official and for 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. Turner and a roll call vote was conducted by President Abele as follows: Adelman-Yes, Giacalone-Yes, Lipsyc-Yes, Kost-Yes, and Turner-Yes.

  8:08 a.m.

Mr. Braylock arrived and joined the Executive Session in progress.

  8:12 a.m.

Ms. Eastman arrived and joined the Executive Session in progress.

  9:15 a.m.

RES. 2002-119  The Executive Session ended and the meeting was opened to the public.  Mr. Lipsyc moved that the Board issue the following Order in the matter of David Angelo Pishotti, R.Ph:

 

(A)     Testimony

 

         State's Witnesses:

 

(1)     None

 

         Respondent's Witnesses:

 

(1)     David Angelo Pishotti, R.Ph., Respondent

(2)     Anita Pampena Perone

(3)     Kent Douglas Potts, R.Ph.

(4)     Joseph Gioiello, R.Ph.

 

(B)      Exhibits

 

         State's Exhibits:

 

(1)     Exhibit 1--Hearing Request letter from Michael D. Rossi dated June 19, 2001.

(2)     Exhibit 1A--Copy of two-page Hearing Schedule letter dated June 25, 2001.

(3)     Exhibit 1B--Copy of Ohio Pharmacist Computer Record of David Angelo Pishotti.

(4)     Exhibit 1C--Letter from Michael D. Rossi dated December 3, 2001.

(5)     Exhibit 2--Copy of six-page Order of the State Board Of Pharmacy, Docket No. D-991103-029 in the matter of David Angelo Pishotti, R.Ph. dated December 16, 1999.

(6)     Exhibit 3--Copy of six-page Order of the State Board Of Pharmacy, Docket No. D-980210-039 in the matter of David Angelo Pishotti, R.Ph. dated September 9, 1998.

(7)     Exhibit 4--Copy of two-page Youngstown Police Department Ohio Uniform Inci­dent Report, Incident No. 98-8347, of David Pishotti dated February 2, 1998, and Youngstown Police Department Suspect/Arrest Supplement, Incident No. 98-8347, of David Pishotti dated February 3, 1998.

(8)     Exhibit 5--Copy of two-page Tri-State Laboratories, Inc. report of drug screen results for urine sample of David Pishotti, Case No. 980164, dated February 4, 1998.

(9)     Exhibit 6--Copy of five-page Mahoning County Drug Task Force Investigative Re­port re David Pishotti dated February 3, 1998, and Inventory of Evidence Seized From David Pishotti.

(10)   Exhibit 7--Copy of two-page CVS Voluntary Statement of David Pishotti dated February 9, 1998.

(11)   Exhibit 8--Copy of Mahoning County Drug Task Force Written Statement of Marsha Vlosich dated July 23, 1998.

(12)   Exhibit 9--Copy of CVS/REVCO #4154 Pharmacist’s Statement for David Pishotti covering December 1, 1997 to February 3, 1998; Copy of two-page Troutman Drug Co. Record of Prescriptions for Dave Pishotti covering January 1, 1997 to February 25, 1998.

(13)   Exhibit 10--Copy of Youngstown Police Department Waiver Of Rights of David Pishotti dated February 3, 1998; Copy of eight-page transcript of Interview of David Angelo Pishotti conducted February 3, 1998.

(14)   Exhibit 11--Copy of two-page Tri-State Laboratories, Inc. report of drug examination results re David Pishotti dated February 17, 1998.

(15)   Exhibit 12--Copy of Bill of Information, State of Ohio vs. David Angelo Pishotti, Case No. 98-CR-377-A, Trumbull County Common Pleas Court, not dated; Copy of  pages 1, 2, 4, and 5 of the Finding On Guilty Plea To Bill Of Information, State of Ohio vs. David Angelo Pishotti, Case No. 98-CR-377-A, Trumbull County Common Please Court, not signed or dated.

 

         Respondent's Exhibits:

 

(1)     Exhibit A--Copy of six-page Order of the State Board Of Pharmacy, Docket No. D-991103-029 in the matter of David Angelo Pishotti, R.Ph. dated December 16, 1999.

(2)     Exhibit B1--Copy of North Park, Inc. contract of David Pishotti dated January 4, 2000.

(3)     Exhibit B2--Copy of two-page PRO Inc. Pharmacist’s Recovery Contract of David Pishotti dated March 20, 2000.

(4)     Exhibit C--Copy of twenty-one drug screen reports for specimens collected from David A. Pishotti from September 10, 1998 to March 30, 2000; Copy of Page 5 of the Order of the Board to David Angelo Pishotti, R.Ph., not dated; Copy of Giant Eagle Pharmacy #4051 Medical Expenses report for March 10, 2000 of David Pishotti dated April 21, 2000, and St. Joseph Family Medical Center-Howland Urgent Care Center Homegoing Instructions sheet for David Pishotti; Copy of nine drug screen reports for specimens collected from David A. Pishotti from April 14, 1998 to November 26, 2001.

(5)     Exhibit D--Letter from Earl Roman, Jr., CCDCI dated November 27, 2001; copy of letter from Susan D. Bancroft, M.S.Ed., LPCC, LSW, CCDCIII dated April 28, 1999; Copy of North Park, Inc. Consent to Treatment/Consent for Service of David Pishotti signed and dated April 20, 1999.

(6)     Exhibit E--Copy of twenty-eight Support Group Attendance Verification Sheets dated from July 9, 1998 through December 26, 2001.

(7)     Exhibit F--Copy of twelve pages of Treatment Program Notes dated from May 13, 1999 through October 2, 2001; Copy of Transfer Summary of David Pishotti dated October 1, 2001; Copy of Treatment Program Notes dated October 22, 2001.

(8)     Exhibit G--Copy of three-page Online Test History for David Pishotti of Total CE credits dated from February 24, 1999 to June 29, 2000; Copy of four Continu­ing Pharmacy Education Certificates of David Pishotti dated May 16, 1999, June 25, 1999, May 1, 2000, May 21, 2000, Copy of two-page listing of Total CE credits showing no name dated from October 25, 2000 to March 28, 2001; Copy of two Continuing Pharmacy Education Certificates of David Pishotti dated February, 2001, and April 29, 2001.

(9)     Exhibit H--Letter from Jose L. Alappatt, M.D. dated November 19, 2001.

(10)   Exhibit I--Letter from Charles J. Beck dated November 30, 2001; Letter from Thomas Savage dated December 17, 2001.

(11)   Exhibit J--Copies of eight letters from Carol M. Noble, R.Ph. dated November 24, 2001, Robert J. Dougherty dated November 28, 2001, Jeffrey Czuba dated November 29, 2001, Joseph C. Salmen dated December 10, 2001, Nick S. dated December 10, 2001, David F. Merk dated December 11, 2001, David Baker dated December 16, 2001 and Keith M. Wire, R.Ph. dated December 16, 2001.

(12)    Exhibit K--Copy of Journal Entry, State of Ohio vs David Pishotti, Case No. 98-CR-377, Trumbull County Common Pleas Court dated October 13, 1999.

(13)    Exhibit L--Support Group Attendance Verification Sheet dated from November 18, 2001 to January 6, 2002.

(14)    Exhibit M--Two-page Bad Check Diversion Unit, Las Vegas, Nevada History Report of David Pishotti printed December 17, 2001.

(15)    Exhibit N-- Copy of letter from David Pishotti, R.Ph. dated September 30, 2000.

 

 

(A)     Every six months from the effective date of this Order, for the term of proba­tion, a written report must be provided by a licensed psychiatrist or psycholo­gist showing compliance with the treatment plan for bipolar disorder as designed by that psychiatrist or psychologist.

 

(B)     David Angelo Pishotti 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 at least once every three months.

 

(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)     Carisoprodol, meprobamate, phentermine, and alcohol must be added to the standard urine drug screen.  A Breathalyzer may be used to test for alcohol, but an appropriately certified individual must conduct the test within twelve hours of notification.

 

(c)     Results of all drug and alcohol 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.

 

(C)     David Angelo Pishotti 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 David Angelo Pishotti's progress towards recovery and what David Angelo Pishotti has been doing during the previous three months.

 

(D)     Other terms of probation are as follows:

 

(1)     The State Board of Pharmacy hereby declares that David Angelo Pishotti'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)     David Angelo Pishotti may not serve as a responsible pharmacist.

 

(3)     David Angelo Pishotti may not destroy, assist in, or witness the destruction of controlled substances.

 

(4)     David Angelo Pishotti must abide by the contract from the treatment provider and any violation must be reported to the Board immedi­ately.

 

(5)     David Angelo Pishotti must not violate the drug laws of the State of Ohio, any other state, or the federal government.

 

(6)     David Angelo Pishotti must abide by the rules of the State Board of Pharmacy.

 

(7)     David Angelo Pishotti must comply with the terms of this Order.

 

 

The motion was seconded by Ms. Eastman and approved by the Board (Aye-5/Nay-1/Abstain-1[Turner]/Absent For Vote-1[Teater]).

 

The Board took a brief recess.

  9:34 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 Michelle M. Solnosky, R.Ph., Euclid.  Mr. Lipsyc recused himself from the hearing.

11:58 a.m.

The hearing ended and the record was closed.  The Board recessed for lunch.

  1:15 p.m.

The meeting resumed in Room 1919 with all members present except Mrs. Teater.  Mr. Keeley discussed his quarterly budget report with the Board.  There were no official actions needed to be taken by the Board on this matter.

  1:33 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 Mark Alan Hoskins, R.Ph., Macedonia.

  5:15 p.m.

Ms. Eastman moved that the Board go into Executive Session 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 Mr. Turner and a roll call vote was conducted by President Abele as follows: Adelman-Yes, Braylock-Yes, Eastman-Yes, Giacalone-Yes, Lipsyc-Yes, Kost-Yes, and Turner-Yes.

  5:40 p.m.

RES. 2002-120  The Executive Session ended and the meeting was opened to the public.  President Abele announced that the hearing in the matter of Mark Alan Hoskins, R.Ph. would be recessed and continued to a later date pending the drafting of a mutually acceptable settlement offer.

  5:45 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 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, and Turner-Yes.

  6:15 p.m.

RES. 2002-121  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 Michelle M. Solnosky, R.Ph.:

 

(A)     Testimony

 

         State's Witnesses:

 

(1)     Mark Kabat, Ohio State Board of Pharmacy

 

         Respondent's Witnesses:

 

(1)     Michelle M. Solnosky, R.Ph., Respondent

 

(B)     Exhibits

 

         State's Exhibits:

 

(1)     Exhibit 1--Copy of five-page Notice of Opportunity for Hearing letter dated March 9, 2001.

(2)     Exhibit 1A--Hearing Request letter from Michelle M. Solnosky, not dated.

(3)     Exhibit 1B--Copy of Hearing Schedule letter dated March 29, 2001.

(4)     Exhibit 1C--Copy of three-page Summary Suspension/Notice of Opportunity For Hearing letter dated April 13, 2001.

(5)     Exhibit 1D--Copy of Ohio State Board Of Pharmacy Certificate Of Mailing for Michelle M. Solnosky dated April 24, 2001; Copy of Ohio State Board Of Phar­macy mailing envelope for Michelle M. Solnosky postage meter-dated April 24, 2001; Copy of Hearing Schedule letter dated March 29, 2001.

(6)     Exhibit 1E--Copy of Letter of Representation from Regis E. McGann dated April 17, 2001.

(7)     Exhibit 1F--Copy of Hearing Schedule letter dated June 20, 2001.

(8)     Exhibit 1G--Copy of Ohio Pharmacist Computer Record of Michelle Margaret Solnosky dated June 21, 2001.

(9)     Exhibit 1H--Copy of Hearing Continuance Request letter from Regis E. McGann dated August 20, 2001.

(10)   Exhibit 1K--Copy of Hearing Schedule letter dated August 21, 2001.

(11)   Exhibit 2--Copy of thirty-two-page Ohio State Board of Pharmacy Report Of Investigation, Regarding Michelle Margaret Solnosky dated November 21, 2000.

(12)   Exhibit 3--Copy of Ohio State Board of Pharmacy Drug Audit Accountability Sheet of Medic #709 for Alprazolam 0.25mg dated December 11, 2000.

(13)   Exhibit 4--Copy of Ohio State Board of Pharmacy Drug Audit Accountability Sheet of Medic #709 for Diazepam 10mg dated December 11, 2000.

(14)   Exhibit 5--Copy of Ohio State Board of Pharmacy Drug Audit Accountability Sheet of Medic #709 for Ambien 10mg dated December 12, 2000.

(15)   Exhibit 6--Copy of Statement of Michelle A. Parrish notarized November 15, 2000.

(16)   Exhibit 7--Copy of Waiver Of Indictment With Counsel, State of Ohio vs. Michelle M. Solnosky, Case No. 402372, Cuyahoga County Common Pleas Court, not dated.

(17)   Exhibit 8--Copy of ten-page Information, State of Ohio vs. Michelle M. Solnosky, Case No. 402372, Cuyahoga County Common Pleas Court, dated March 15, 2001.

(18)   Exhibit 9--Copy of Journal Entry, State of Ohio vs. Michelle M. Solnosky, Case No. CR 402372, Cuyahoga County Common Pleas Court, dated May 24, 2001.

 

         Respondent's Exhibits:

 

(1)     Exhibit A--Copy of Motion To Terminate Probation And/Or Community Control, State of Ohio vs. Michelle M. Solnosky, Case No. CR 402372, Cuyahoga County Common Pleas Court, not dated.

(2)     Exhibit B--Copy of Journal Entry, State of Ohio vs. Michelle M. Solnosky, Case No. CR 402372, Cuyahoga County Common Pleas Court, dated January 4, 2002.

(3)     Exhibit C--Letter from Michelle Solnosky, not dated.

(4)     Exhibit D--Letter from Wendy S. Gartz, R.Ph. dated December 23, 2001.

(5)     Exhibit E--Letter from Anita Barnes dated December 27, 2001.

(6)     Exhibit F--Copy of letter from Don E. Hissam, R.Ph. dated January 7, 2001.

 

(1)     Records of the State Board of Pharmacy indicate that Michelle M. Solnosky was originally licensed by the State of Ohio on July 24, 1997, pursuant to examination,  and that her license to practice pharmacy in the state of Ohio was summarily suspended effective April 13, 2001.  Further, the records indicate that Michelle M. Solnosky was the Responsible Pharmacist at Medic Discount Drug; 709 East 185th Street, Cleveland, Ohio 44119 pursuant to Sections 4729.27 and 4729.55 of the Ohio Revised Code and Rule 4729-5-11 of the Ohio Administrative Code.

 

(2)     Michelle M. Solnosky did, on or about February, 2000, with purpose to deprive, knowingly obtain or exert control over dangerous drugs, the property of Medic Discount Drug, beyond the express or implied consent of the owner, to wit: Michelle M. Solnosky admittedly stole approximately 15 to 20 doses of Alprazolam 0.25mg, a Schedule IV controlled substance, for her personal use without a prescription.  Such conduct is in violation of Section 2913.02 of the Ohio Revised Code.

 

(3)     Michelle M. Solnosky did, on or about August, 2000, through September, 2000, with purpose to deprive, knowingly obtain or exert control over dangerous drugs, the property of Medic Discount Drug , beyond the express or implied consent of the owner, to wit: Michelle M. Solnosky admittedly stole approxi­mately 20 doses of Diazepam 10mg, a Schedule IV controlled substance, for her personal use without a prescription.  Such conduct is in violation of Section 2913.02 of the Ohio Revised Code.

 

(4)     Michelle M. Solnosky did, on or about September, 2000, with purpose to deprive, knowingly obtain or exert control over dangerous drugs, the property of Medic Discount Drug, beyond the express or implied consent of the owner, to wit: Michelle M. Solnosky admittedly stole approximately 21 doses of Prozac 20mg, a dangerous drug, for her personal use without a prescription.  Such conduct is in violation of Section 2913.02 of the Ohio Revised Code.

 

(5)     Michelle M. Solnosky did, on or about March, 2000, with purpose to deprive, knowingly obtain or exert control over dangerous drugs, the property of Medic Discount Drug, beyond the express or implied consent of the owner, to wit: Michelle M. Solnosky admittedly stole approximately 20 doses of Sonata 10mg, a Schedule IV controlled substance, for her personal use without a prescription.  Such conduct is in violation of Section 2913.02 of the Ohio Revised Code.

 

(6)     Michelle M. Solnosky did, on or about February, 2000, with purpose to deprive, knowingly obtain or exert control over dangerous drugs, the property of Medic Discount Drug, beyond the express or implied consent of the owner, to wit: Michelle M. Solnosky admittedly stole approximately 20 doses of Ambien 10mg, a Schedule IV controlled substance, for her personal use without a prescription.  Such conduct is in violation of Section 2913.02 of the Ohio Revised Code.

 

(7)     Michelle M. Solnosky did, on or about May, 1997, through October, 2000, with purpose to deprive, knowingly obtain or exert control over dangerous drugs, the property of Medic Discount Drug, beyond the express or implied consent of the owner, to wit: Michelle M. Solnosky admittedly stole approximately eight doses of Prilosec 20mg, a dangerous drug, for her personal use without a prescription.  Such conduct is in violation of Section 2913.02 of the Ohio Revised Code.

 

(8)     Michelle M. Solnosky did, on or about October, 1998, with purpose to deprive, knowingly obtain or exert control over dangerous drugs, the property of Medic Discount Drug,  beyond the express or implied consent of the owner, to wit: Michelle M. Solnosky admittedly stole approximately two doses of Roxicet 5/325mg, a Schedule II controlled substance, for her personal use without a prescription.  Such conduct is in violation of Section 2913.02 of the Ohio Revised Code.

 

(9)     Michelle M. Solnosky did, on or about May, 1997, through October, 2000, knowingly use the property of Medic Discount Drug, without the consent of the owner, to wit: Michelle M. Solnosky admittedly took Prilosec, a dangerous drug, for her personal use from the drug stock of the pharmacy, yet she replaced it the next day with Prilosec that was located at her residence that had been dispensed to her.  Such conduct is in violation of Section 2913.04 of the Ohio Revised Code.

 

(10)   Michelle M. Solnosky did, on or about October, 1998, knowingly use the property of Medic Discount Drug, without the consent of the owner, to wit: Michelle M. Solnosky admittedly took Roxicet 5/325mg, a Schedule II controlled substance, for her personal use from the drug stock of the pharmacy, yet she replaced it the next day with Roxicet that was located at her residence that had been dispensed to her.  Such conduct is in violation of Section 2913.04 of the Ohio Revised Code.

 

(11)   Michelle M. Solnosky did, on or about July, 1998, attempt to furnish another a sample drug, to wit: Michelle M. Solnosky admittedly placed approximately 20 to 30 physician sample doses of Detrol 2mg, a dangerous drug, into the drug stock for dispensing at Medic Discount Drug.  The expiration date of the samples had passed before the drugs were dispensed to patients.  Such conduct is in violation of Section 2923.02 of the Ohio Revised Code as it relates to Section 2925.36 of the Ohio Revised Code.

 

(12)   Michelle M. Solnosky did, on or about July, 1998, attempt to furnish another a sample drug, to wit: Michelle M. Solnosky admittedly placed approximately 20 physician sample doses of Depakote 250mg, a dangerous drug, into the drug stock for dispensing at Medic Discount Drug.  The expiration date of the samples had passed before the drugs were dispensed to patients.  Such conduct is in violation of Section 2923.02 of the Ohio Revised Code as it relates to Section 2925.36 of the Ohio Revised Code.

 

(13)   Michelle M. Solnosky did, on or about July, 1998, attempt to furnish another a sample drug, to wit: Michelle M. Solnosky admittedly placed approximately 50 to 60 physician sample doses of Tegretol 200mg, a dangerous drug, into the drug stock for dispensing at Medic Discount Drug.  The expiration date of the samples had passed before the drugs were dispensed to patients.  Such conduct is in violation of Section 2923.02 of the Ohio Revised Code as it relates to Section 2925.36 of the Ohio Revised Code.

 

(1)     Upon consideration of the record as a whole, the State Board of Pharmacy con­cludes that paragraphs (2) through (13) 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 (13) 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 (11), (12), and (13) 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)     Michelle M. Solnosky, 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)     Michelle M. Solnosky, 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)     Michelle M. Solnosky 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)     Michelle M. Solnosky 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 Michelle M. Solnosky’s fitness for readmission into the practice of pharmacy;

 

(3)     Successful completion of the Multistate Pharmacy Jurisprudence Examina­tion, or an equivalent examination approved by the Board.  If Michelle M. Solnosky has not successfully completed the examination prior to the reinstatement petition hearing, her license will remain under suspension until this condition has been achieved.

 

(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.

 

(C)     If reinstatement is not accomplished within three years of the effective date of this Order, Michelle M. Solnosky must show successful completion of the NAPLEX examination or an equivalent examination approved by the Board.

 

 

The motion was seconded by Mr. Kost and approved by the Board (Aye-6/Nay-0/­Abstain-1[Lipsyc]).

 

RES. 2002-122  Mr. Braylock then moved that the Board issue the following Order in the matter of CVS/pharmacy #3131:

 

(A)     Testimony

 

         State's Witnesses:

 

(1)     James Reye, Ohio State Board of Pharmacy

 

         Respondent's Witnesses:

 

(1)     Richard Kolezynski

(2)     Scott Komatz

(3)     Steven Heidenthal

 

(B)     Exhibits

 

         State's Exhibits:

 

(1)     Exhibit 1--Copy of four-page Notice of Opportunity for Hearing letter dated March 12, 2001.

(2)     Exhibit 1A--Copy of three-page letter from Richard Kolezynski, R.Ph. dated March 20, 2000; Copy of three-page CVS/pharmacy "Explanation of Corrective Action Taken Regarding Pink Slip Issued March 8, 2000"; Copy of CVS/phar­macy "Explanation of Corrective Action Taken Regarding Pink Slip Issued March 9, 2000"; Copies of two CVS/pharmacy Memos Re Pharmacy Alarms dated March 20, 2000.

(3)     Exhibit 1B--Copy of two-page letter from Richard Kolezynski, R.Ph. dated April 2, 2001.

(4)     Exhibit 1C--Copy of Hearing Request letter from Susan M. DelMonico, R.Ph., J.D. dated April 3, 2001.

(5)     Exhibit 1D--Copy of Hearing Schedule letter dated April 5, 2001.

(6)     Exhibit 1E--Two-page letter from Susan DelMonico, R.Ph., J.D. dated April 3, 2001.

(7)     Exhibit 1F--Copy of letter from David L. Rowland to Susan DelMonico, R.Ph., J.D. dated May 15, 2001.

(8)     Exhibit 1G--Copy of Hearing Schedule letter dated May 17, 2001.

(9)     Exhibit 1H--Copy of Ohio Dangerous Drug Distributor Computer Record of CVS/pharmacy #3131.

(10)   Exhibit 1I--Notice of Appearance as Counsel letter from James Flynn dated Septem­ber 17, 2001.

(11)   Exhibit 1J-- Copy of Ohio Pharmacist Computer Record of Pamela A. McIntyre.

(12)   Exhibit 1K--Letter from James F. Flynn dated October 2, 2001.

(13)   Exhibit 1L--Letter from David Rowland to James F. Flynn, Esq. dated October 19, 2001.

(14)   Exhibit 1M--Copy of Hearing Schedule letter dated November 8, 2001.

(15)   Exhibit 2--Statement of Deborah Evilsizer notarized March 8, 2000.

(16)   Exhibit 3--Two-page Statement of Deborah Evilsizer notarized March 21, 2000.

(17)   Exhibit 4--Two-page Statement of Michael J. Kolpien notarized March 8, 2000.

(18)   Exhibit 5--Two-sided Third Party/Consultation Log Sheet of CVS/pharmacy #3131 with Rx stickers dated March 7, 2000.

(19)   Exhibit 6--Two-sided Third Party/Consultation Log Sheet of CVS/pharmacy #3131 with Rx stickers dated from March 3, 2000 to March 7, 2000.

(20)   Exhibit 7--Copy of three-page Dangerous Drug Distributor Inspection Report for CVS/pharmacy #3131 dated March 8, 2000.

(21)   Exhibit 8--Copy of three-page letter from Richard Kolezynski, R.Ph. dated March 20, 2000; Copy of three-page CVS/pharmacy "Explanation of Corrective Action Taken Regarding Pink Slip Issued March 8, 2000"; Copy of CVS/pharmacy "Explanation of Corrective Action Taken Regarding Pink Slip Issued March 9, 2000".

(22)   Exhibit 9--Copy of Electronic Journal Report for RX Item 000018653603 dated March 9, 2000, with handwritten note and stickers for Prescription 186536 dated March 7, 2000.

(23)   Exhibit 10--Copy of CVS/REVCO #3131 Pharmacist's Statement covering October 13, 1999 through March 13, 2000 dated March 13, 2000.

(24)   Exhibit 11--Copy of Electronic Journal Report for RX Item 000019223101 dated March 9, 2000, with handwritten note and stickers for Prescription 192231 dated March 7, 2000.

(25)   Exhibit 12-- Copy of CVS/REVCO #3131 Pharmacist's Statement covering October 13, 1999 through March 13, 2000 dated March 13, 2000.

(26)   Exhibit 13--Copy of Electronic Journal Report for RX Items 000019114101, 000019002502, and 000019002702 dated March 9, 2000, with handwritten note and stickers for Prescriptions 191141, 190025, and 190027 dated March 7, 2000.

(27)   Exhibit 14--Copy of two-page CVS/REVCO #3131 Pharmacist's Statement covering October 13, 1999 through March 13, 2000 dated March 13, 2000.

(28)   Exhibit 15--Copy of Electronic Journal Report for RX Items 000019408500 and 000019408400 dated March 9, 2000, with handwritten note and stickers for Prescriptions 194085 and 194084 dated March 7, 2000.

(29)   Exhibit 16--Copy of four-page CVS/REVCO #3131 Pharmacist's Statement covering October 13, 1999 through March 13, 2000 dated March 13, 2000.

(30)   Exhibit 17--Copy of Electronic Journal Report for RX Item 000019412200 dated March 9, 2000, with handwritten note and stickers for Prescription 194122 dated March 7, 2000.

(31)   Exhibit 18--Copy of two-page CVS/REVCO #3131 Pharmacist's Statement covering October 13, 1999 through March 13, 2000 dated March 13, 2000.

(32)   Exhibit 19--Copy of Electronic Journal Report for RX Item 000019412000 dated March 9, 2000, with handwritten note and stickers for Prescription 194120 dated March 7, 2000.

(33)   Exhibit 20--Copy of CVS/REVCO #3131 Pharmacist's Statement covering October 13, 1999 through March 13, 2000 dated March 13, 2000.

(34)   Exhibit 21--Copy of Electronic Journal Report for RX Items 000019408300 and 000019408200 dated March 9, 2000, with handwritten note and stickers for Prescriptions 194083 and 194082 dated March 7, 2000.

(35)   Exhibit 22--Copy of two-page CVS/REVCO #3131 Pharmacist's Statement covering October 13, 1999 through March 13, 2000 dated March 13, 2000.

(36)   Exhibit 23--Copy of Electronic Journal Report for RX Item 000018950702 dated March 9, 2000, with handwritten note and stickers for Prescription 189507 dated March 7, 2000.

(37)   Exhibit 24--Copy of CVS/REVCO #3131 Pharmacist's Statement covering October 13, 1999 through March 13, 2000 dated March 13, 2000.

(38)   Exhibit 25--Copy of Electronic Journal Report for RX Item 000019413800 dated March 9, 2000, with handwritten note and stickers for Prescription 194138 dated March 7, 2000.

(39)   Exhibit 26--Copy of CVS/REVCO #3131 Pharmacist's Statement covering October 13, 1999 through March 13, 2000 dated March 13, 2000.

(40)   Exhibit 27--Copy of Electronic Journal Report for RX Items 000018535504, 000018535304, and 000018535404 dated March 9, 2000, with handwritten note and stickers for Prescriptions 185355, 185353, 185354 dated March 7, 2000.

(41)   Exhibit 28--Copy of two-page CVS/REVCO #3131 Pharmacist's Statement covering October 13, 1999 through March 13, 2000 dated March 13, 2000.

(42)   Exhibit 29--Envelope dated March 4, 2000 containing Front and Pharmacy codes.

(43)   Exhibit 30--Copy of Terminal Distributor Notification of Change of Responsible Person form of Brian G. Rose dated November 21, 1999.

(44)   Exhibit 31--Copy of Change of Employment form of Brian G. Rose dated February 22, 2000.

(45)   Exhibit 32--Copy of Notification of Change of Responsible Person form of Pamela A. McIntyre effective March 9, 2000.

 

         Respondent's Exhibits:

 

(1)     Exhibit A--Copy of "Facts Regarding Store #3131 - Board of Pharmacy Violation", not dated.

(2)     Exhibit B--Copy of three-page CVS/pharmacy "Explanation of Corrective Action Taken Regarding Pink Slip Issued March 8, 2000.

(3)     Exhibit C--Copy of CVS/pharmacy "Explanation of Corrective Action Taken Regarding Pink Slip Issued March 9, 2000".

(4)     Exhibit D--Copy of two-page "Procedures for Closing a CVS Pharmacy", not dated.

(5)     Exhibit E--Copy of CVS/REVCO #3131 Dispensing Time Report for March 8, 2000.

(6)     Exhibit F--Copy of Coaching & Counseling Form dated March 16, 2000.

(7)     Exhibit G--Copy of Coaching & Counseling Statement of Mike Kolpien dated March 17, 2000.

(8)     Exhibit H--Copy of CVS/pharmacy Memo re Pharmacy Alarms-Pharmacy Security Baseline Practices (State of Ohio) dated March 20, 2000.

(9)     Exhibit I--Copy of CVS/pharmacy Memo re Pharmacy Alarms-Pharmacy Security Baseline Practice dated March 20, 2000.

(10)   Exhibit J--Copy of “Urgent Message” to pharmacists from Rick Kolezynski, not dated.

(11)   Exhibit K--Copy of eight-page CVS procedures titled, "Topic: Pharmacy Access/­Alarm", dated August 1998.

(12)   Exhibit L--Copy of Personnel Change Of Status form of Brian Rose dated Febru­ary 20, 2000.

(13)   Exhibit M--Copy of two-page HRSA News Release titled "HHS Report Finds Emerging Shortage of Licensed Pharmacists" dated December 12, 2000.

(14)   Exhibit N--Copy of five-page Introduction and ninety-one-page Report To Congress re "The Pharmacist Workforce: A Study of the Supply and Demand for Pharmacists" made by the Department of Health and Human Services/Health Resources and Services Administration/Bureau of Health Professions dated December 2000.

(15)   Exhibit O--Affidavit of Michael J. Kolpien notarized November 2, 2001 with attached copy of five-page handwritten statement of Michael J. Kolpien dated March 10, 2000.

(16)   Exhibit P--Copy of CVS/pharmacy Memo re Pharmacy Alarm/Access Baseline Practices dated April 10, 2000.

 

(1)     Records of the State Board of Pharmacy indicate that Pamela A. McIntyre was the Responsible Pharmacist at CVS/pharmacy #3131 pursuant to Rule 4729-5-11 of the Ohio Administrative Code and Sections 4729.27 and 4729.55 of the Ohio Revised Code at the time of the occurrences documented in the Notice of Opportunity For Hearing dated March 12, 2001.

 

(2)     CVS/pharmacy #3131 did, on or about March 8, 2000, cease to satisfy the qualifications of a terminal distributor of dangerous drugs set forth in Section 4729.55 of the Ohio Revised Code, to wit: a pharmacist did not maintain super­vision and con­trol over the possession and custody of the dangerous drugs; and adequate safe­guards were not assured to prevent the sale or other dis­tribution of dangerous drugs by persons other than a pharmacist or licensed health professional author­ized to prescribe drugs.  On said date, a Board agent observed activities, defined as the practice of pharmacy, occurring when a phar­macist was not present in the store.  Such conduct constitutes ceasing to satisfy the qualifications of a terminal distributor within the meaning of Section 4729.57 of the Ohio Revised Code.

 

(3)     CVS/pharmacy did, on or about March 8, 2000, permit persons not a pharma­cist or a pharmacy intern under the personal supervision of a pharmacist to dispense or sell dangerous drugs or otherwise engage in the practice of phar­macy, to wit: the following prescriptions were dispensed by non-pharmacists:

 

Prescription #

     

Drug

   

Quantity

185355

 

Prozac 20mg

 

30

185354

 

Norvasc 5mg

 

30

185353

 

Prinivil 40mg

 

30

194138

 

Methotrexate 2.5mg

 

12

189507

 

Wellbutrin SR

 

60

194083

 

Imdur 30mg

 

34

194082

 

Coumadin 2.5mg

 

50

194120

 

Diprolene AF 0.05%

 

15

194122

 

Prevacid 30mg

 

30

194084

 

Warfarin Sodium 2.5mg

 

60

194085

 

Furosemide 40mg

 

15

191141

 

Urex 1gm

 

30

190025

 

Lorazepam 2mg

 

90

190027

 

Nortriptyline HCL

 

60

192231

 

Clomiphene Citrate 50mg

 

5

186536

 

Hydrochlorothiazide 25mg

 

30

 

         Such conduct is in violation of Section 4729.28 of the Ohio Revised Code.

 

(4)     CVS/pharmacy did, on or about March 8, 2000, fail to offer or otherwise perform patient counseling, to wit: when dispensing medications to patients pursuant to the prescriptions listed in paragraph (3) above, pharmacists were not available to offer patient counseling, to counsel patients, or to document refusal.  Such conduct is in violation of Rule 4729-5-22 of the Ohio Admini­strative Code.

 

(5)     CVS/pharmacy did, from January 31, 2000, through March 8, 2000, fail to employ a pharmacist in full and actual charge of the pharmacy, to wit: the phar­macy did not have a responsible pharmacist during this time period.  Such conduct is in violation of Section 4729.27 of the Ohio Revised Code and Rule 4729-5-11 of the Ohio Administrative Code.

 

(6)     CVS/pharmacy did, from January 31, 2000, through March 8, 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.

 

(1)     Upon consideration of the record as a whole, the State Board of Pharmacy con­cludes that paragraphs (4) through (6) of the Findings of Fact constitute violating any rule 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 (3) and (5) of the Findings of Fact constitute violating the provisions of Chapter 4729. of the Revised Code as provided in Division (A)(3) 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 paragraph (2) of the Findings of Fact constitutes ceasing to satisfy the qualifications of a terminal distributor of dangerous drugs 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 paragraph (1) of the Conclusions of Law set forth above, the State Board of Pharmacy hereby revokes the terminal distributor license, No. 02-0748850, held by CVS/pharmacy #3131 effective as of the date of the mailing of this Order.

 

(B)     On the basis of the Findings of Fact and paragraph (2) of the Conclusions of Law set forth above, the State Board of Pharmacy hereby revokes the terminal distributor license, No. 02-0748850, held by CVS/pharmacy #3131 effective as of the date of the mailing of this Order.

 

(C)     On the basis of the Findings of Fact and paragraph (2) of the Conclusions of Law set forth above, the State Board of Pharmacy hereby revokes the terminal distributor license, No. 02-0748850, held by CVS/pharmacy #3131 effective as of the date of the mailing of this Order.

 

 

The motion was seconded by Mr. Kost and approved by the Board (Aye-5/Nay-2).

 

RES. 2002-123  Mr. Giacalone then moved that, pursuant to Section 3719.121 of the Revised Code, the Board summarily suspend the license to practice pharmacy belonging to Karen Frederick, R.Ph. (03-1-17313) due to the fact that a continuation of her professional practice presents a danger of immediate and serious harm to others.  The motion was seconded by Mr. Kost and approved by the Board (Aye-7/Nay-0).

  6:25 p.m.

Mr. Lipsyc moved that the Board receive Per Diem as follows:

 

PER DIEM

 

01/07

 

01/08

 

01/09

 

Total

Abele

 

1

 

1

 

1

 

3

Adelman

 

1

 

1

 

1

 

3

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

Turner

 

1

 

1

 

1

 

3

 

The motion was seconded by Mrs. Adelman and approved by the Board (Aye-7/Nay-0).

  6:26 p.m.

Mr. Giacalone moved that the meeting be adjourned.  The motion was seconded by Mrs. Adelman and approved (Aye-7/Nay-0).

 

 

 

THE BOARD APPROVED THESE MINUTES ON JANUARY 8, 2002