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.

 

 

 

STATE BOARD OF PHARMACY; 77 SOUTH HIGH STREET, ROOM 1702; COLUMBUS, OHIO 43215-6126

Tel:  614/466-4143                         Fax:  614/752-4836                      Email:  exec@bop.state.oh.us

 

 

 

Minutes Of The Meeting

Ohio State Board of Pharmacy

December 8 & 9, 2003

 

MONDAY, DECember 8, 2003

 

10:15 a.m.

ROLL CALL

 

 

The State Board of Pharmacy convened in Room East-B, 31st Floor, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio with the following members present:

 

Robert P. Giacalone, R.Ph. (President); Diane C. Adelman, R.Ph.; Suzanne R. Eastman, R.Ph.; Elizabeth I. Gregg, R.Ph.; Nathan S. Lipsyc, R.Ph.; Dorothy S. Teater, Public Mem­ber; and James E. Turner, R.Ph.

 

Also present were William T. Winsley, Executive Director; Timothy Benedict, Assistant Executive Director; William McMillen, Licensing Administrator; Mark Keeley, Legislative Affairs Administrator; David Rowland, Legal Affairs Administrator; Robert Cole, Compli­ance Supervisor; and Sally Ann Steuk, Assistant Attorney General.

 

The Board discussed the 2004 NABP/AACP District IV meeting which they will be hosting with The Ohio State University College of Pharmacy.  The Board members agreed that the District IV meeting dates should be November 3-5, 2004 and that the site should be the Blackwell Center on the campus of The Ohio State University.

 

After discussion of the draft minutes from the November 3, 4, 5, 2003 meeting, Mrs. Adelman moved that they be approved as amended.  The motion was seconded by Mrs. Gregg and approved by the Board (Aye-6/Nay-0).

10:27 a.m.

 

Mrs. Gregg moved that the Board go into Executive Session for the purpose of the inves­ti­gation of complaints regarding licensees and registrants pursuant to Section 121.22(G)(1) of the Revised Code.  The motion was seconded by Mrs. Teater and a roll call vote was conducted by President Giacalone as follows: Adelman-Yes, Eastman-Yes, Gregg-Yes, Lipsyc-Yes, Teater-Yes, and Turner-Yes.

10:42 a.m.

 

Board Member Gregory Braylock arrived and joined the meeting in progress.

12:00 p.m.

R-2004-090

The Executive Session ended and the meeting was opened to the public.  Ms. Eastman moved that the Board summarily suspend the license to practice pharmacy belonging to Venubabu Talasila, R.Ph. (03-1-24354) due to the fact that a continuation of his professional practice presents a danger of immediate and serious harm to others.  The motion was seconded by Mrs. Gregg and approved by the Board (Aye-6/Nay-0/Abstain-1[Braylock]).

 

R-2004-091

Mrs. Adelman moved that the Board accept the settlement offer received in the matter of Kelly Lutz.  The motion was seconded by Mr. Turner and approved by the Board (Aye-5/Nay-2).  The agreement will become final upon the signature of all parties.

 

R-2004-092

Ms. Eastman moved that the Board accept the settlement offer received in the matter of Samuel Postolski.  The motion was seconded by Mrs. Teater and approved by the Board (Aye-6/Nay-1).  The agreement will become final upon the signature of all parties.

12:16 p.m.

 

The Board recessed for lunch.

  1:58 p.m.

 

The Board reconvened in Room 1960, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio with the following members present:

 

Robert P. Giacalone, R.Ph. (President); Diane C. Adelman, R.Ph.; Gregory Braylock, R.Ph.; Suzanne R. Eastman, R.Ph.; Elizabeth I. Gregg, R.Ph.; Nathan S. Lipsyc, R.Ph.; Dorothy S. Teater, Public Mem­ber; and James E. Turner, R.Ph.

 

R-2004-093

After a discussion of the results of the Public Hearing on the new and proposed rules, Mr. Braylock moved that the following rules be filed with an effective date of January 1, 2004.  The motion was seconded by Mrs. Gregg and approved by the Board (Aye-7/Nay-0).

 

 

( KEY >>   UNDERLINE = Add New Language     STRIKE THROUGH = Remove Language )

 

 

4729-5-31  Criteria for licensure by examination.

 

 

(A)

Pursuant to section 4729.07 of the Revised Code:

 

 

(1)

The examination shall consist of the "North American Pharmacist Licen­sure Examination (NAPLEX)" and a jurisprudence examination compiled by the state board of pharmacy or the "National Association of Boards of Phar­macy (NABP)."

 

 

(2)    (a)

The minimum passing score for the NAPLEX is seventy-five.  Any candidate failing to attain a score of seventy-five on the NAPLEX examination will be required to repeat the NAPLEX examination and remit the fee established by the state board of pharmacy for re-examination.

 

 

(b)

Pursuant to the procedures established by the NABP, a candi­date may transfer his/her NAPLEX score to Ohio only after the candidate has met all of the requirements set by the board for examination and licensure in Ohio.

 

 

(3)

The minimum passing score for the jurisprudence examination is seventy-five.  Any candidate who fails to receive a score of seventy-five on the jurisprudence examination will be required to repeat the juris­prudence examination and remit the fee established by the state board of pharmacy for re-examination.

 

 

(B)

Pursuant to section 4729.13 of the Revised Code:

 

 

(1)

The examination shall consist of the "North American Pharmacist Licen­sure Examination (NAPLEX)" and a jurisprudence examination compiled by the state board of pharmacy or the "National Association of Boards of Phar­macy (NABP)."

 

 

(2)

The minimum passing scores for renewal of the pharmacist's iden­ti­fi­ca­tion card is a seventy-five on each exam.

 

 

(a)

Any candidate for renewal of an identification card who fails to receive a score of seventy-five on the jurisprudence ex­ami­na­tion shall make application and remit the fee estab­lished by the state board of pharmacy for re-examination.

 

 

(b)

Any candidate for renewal of an identification card who fails to receive a score of seventy-five on the NAPLEX examination shall make application and remit the fee established by the state board of pharmacy for re-examination.

 

 

(C)

Pursuant to section 4729.08 of the Revised Code:

 

Applicants for examination and registration as a pharmacist who are gradu­ates of schools or colleges of pharmacy located outside the United States and who are using an approved examination to establish equivalency of their education shall:

 

 

(1)

Obtain a score no lower than seventy-five on the "Foreign Pharmacy Graduate Equivalency Examination (FPGEE)"; and

 

 

(2)

Show oral proficiency in English by successful completion of the "Test of Spoken English (TSE)" or its equivalent, pursuant to rule 4729-5-34 of the Administrative Code.

 

 

(D)

Any examination candidate who fails to take both of the required ex­ami­na­tions within twelve months from the date the board receives the appli­ca­tion materials shall submit a new application for the required ex­ami­na­tion or examinations and remit the fee established by the state board of phar­macy.

 

 

(E)

The record of the passing score for an examination candidate who takes both of the required examinations, but successfully only completes one ex­ami­na­tion will:

 

 

(1)

Be maintained if no more than twelve months has elapsed between attempts to successfully complete the remaining examination.

 

 

(2)

Not be maintained if more than twelve months has elapsed between attempts to successfully complete the remaining examination.  It will then be necessary for the examination candidate to repeat both exami­nations for Ohio licensure.

 

 

(F)

Any candidate who has requested to transfer their NAPLEX score to Ohio must receive a passing score on take the Ohio jurisprudence examination within twelve months from the date the board receives the initial application or the transfer of their candidate completed the NAPLEX examination or the score transfer will be denied.

 

 

4729-7-01  Definitions.

 

As used in Chapter 4729-7 of the Administrative Code:

 

 

(A)

"Continuing pharmacy education", as required in section 4729.12 of the Revised Code, is defined as post-registration pharmacy education of approved quality undertaken to maintain professional competency to practice pharmacy, improve professional skills and preserve uniform qualifications for continuing the practice of the profession for the purpose of protecting public health and welfare.

 

 

(B)

"Continuing education unit (C.E.U.)" is defined as ten contact hours of par­ti­ci­pa­tion in an organized continuing pharmacy education experience pre­sented by an approved provider.

 

 

(C)

"Approved continuing education" is defined as participation in an organized and structured continuing pharmacy education experience which has been presented by an approved provider or the state board of pharmacy and which presents information directly related to the practice of pharmacy in the area of patient care, pharmacy jurisprudence, or pharmacy management.

 

 

(D)

"Approved provider" is defined as an individual, institution, organization, associa­tion, corporation, or agency that has been approved by the state board of phar­macy and/or the "American Council on Pharmaceutical Edu­ca­tion" (A.C.P.E.).

 

 

(E)

"Evidence of approved C.E.U.s" is defined as a certificate or other document cer­tifying that the pharmacist has satisfactorily participated in an organized and structured continuing pharmacy education experience which was pre­sented by an approved provider.

 

 

(F)

"Patient care" related continuing education shall include continuing pharmacy education experi­ences dealing with the properties and actions of drugs and dosage forms; the etiology, charac­teristics, therapeutics and prevention of disease states; and the monitoring and management of patients by the pharma­cist.

 

 

(G) (F)

"Pharmacy jurisprudence" related continuing education shall include Ohio state board of pharmacy approved continuing pharmacy education ex­peri­ences that deal with current laws, rules, and regulations dealing with the prac­tice of phar­macy and the recent changes that have occurred to those laws, rules, and regu­lations.

 

 

(H)

"Pharmacy management" related continuing education shall include continuing pharmacy educa­tion experiences that deal with professional practice management or the behavioral, social, or economic aspects of health care.

 

 

4729-9-14  Records of controlled substances.

 

 

(A)

Each prescriber or terminal distributor of dangerous drugs shall keep a record of all controlled substances received, administered, dispensed, sold, or used.

 

 

(1)

Records of receipt shall contain a description of all controlled substances received, the kind and quantity of controlled substances received, the name and address of the persons from whom received, and the date of receipt.

 

 

(2)

Records of administering, dispensing, or using controlled substances shall contain a description of the kind and quantity of the controlled substance administered, dispensed, or used, the date, the name and address of the person to whom or for whose use, or the owner and iden­tification of the animal for which, the controlled substance was admini­stered, dispensed, or used.

 

 

(3)

Records of drugs administered which become a permanent part of the patient's medical record shall be deemed to meet the name and address requirements of paragraph (A)(2) of this rule.

 

 

(B)

Each prescriber or terminal distributor of dangerous drugs shall maintain an inventory of all con­trolled substances as follows:

 

 

(1)

Each inventory shall contain a complete and accurate record of all con­trolled substances on hand on the date the inventory is taken.

 

 

(a)

The name of the substance.

 

 

(b)

The total quantity of the substance.

 

 

(i)

Each finished form (e.g., ten-milligram tablet or ten-milligram concentration per fluid ounce or milliliter).

 

 

(ii)

The number of units or volume of each finished form in each commercial container (e.g., one-hundred-tablet bottle or ten-milliliter vial).

 

 

(iii)

The number of commercial containers of each such fin­ished form (e.g., three one-hundred-tablet bottles or ten one-milliliter vials).

 

 

(c)

If the substance is listed in schedule I or II, the prescriber or terminal distributor of dangerous drugs shall make an exact count or measure of the contents.

 

 

(d)

If the substance is listed in schedule III, IV, or V, the prescriber or terminal distributor of dangerous drugs shall may make an estimated count or measure of the contents, unless the container holds more than one thousand tablets or capsules in which an exact count of the contents must be made.

 

 

(2)

A separate inventory shall be made for each place or establishment where controlled sub­stances are in the possession or under the control of the prescriber or terminal distributor.  Each inventory for each place or establishment shall be kept at the place or estab­lish­ment.

 

 

(3)

An inventory of all stocks of controlled substances on hand on the date the prescriber or terminal distributor first engages in the administer­ing, dispensing, or use of controlled sub­stances. In the event the pre­scriber or terminal distributor of dangerous drugs commences business with no controlled substances on hand, this fact shall be recorded as the initial inventory.

 

 

(4)

Each prescriber or terminal distributor of dangerous drugs shall take a new inventory of all stocks of controlled substances on hand every two years following the date on which the initial inventory is taken.

 

 

(5)

When a substance is added to the schedule of controlled substances by the federal drug enforcement administration or the state board of phar­macy, each prescriber or terminal dis­tributor of dangerous drugs shall take an inventory of all stock of such substance on hand at that time.

 

 

(6)

All records of receipt, distribution, administering, dispensing, inven­tory, or using controlled substances shall be kept for a period of three years at the place where the controlled sub­stances are located.  Any prescriber or terminal distributor of dangerous drugs intending to main­tain such records at a location other than this place must first send notification to the state board of pharmacy; if not contested by the board within sixty days, it will stand as approved.

 

 

4729-9-22  Records of dangerous drugs.

 

Each prescriber or terminal distributor of dangerous drugs shall keep a record of all dan­ger­ous drugs received, administered, dispensed, distributed, sold, destroyed, or used.

 

 

(A)

Records of receipt shall contain a description of all dangerous drugs received, the kind and quantity of dangerous drugs received, the name and address of the persons from whom received, and the date of receipt.

 

 

(B)

Records of administering, dispensing, or using dangerous drugs shall contain a description of the kind and quantity of the dangerous drugs administered, dis­pensed, sold, or used, the date, the name and address of the person to whom or for whose use, or the owner and identification of the animal for which, the dan­gerous drug was administered, dispensed, or used.

 

 

(C)

Records of dangerous drugs, other than controlled substances, administered, dis­pensed, or used which become a permanent part of the patient's medical record shall be deemed to meet the requirements of paragraph (B) of this rule.

 

 

(D)

All records of receipt, distribution, administering, dispensing, selling, destroying, or using dangerous drugs shall be kept for a period of three years at the place where the dangerous drugs are located.  Any terminal distributor of dangerous drugs intending to maintain such records at a location other than this place must first send notification to the state board of pharmacy by certified mail, return re­ceipt requested; if not contested by the board within sixty days, it will stand as approved.  A copy of the request with the return receipt shall be maintained with the other records of danger­ous drugs.  Any such alternate location shall be secured and accessible only to representatives of the termi­nal distributor.

 

 

4729-9-24  Retail and wholesale sales of dangerous drugs on-line.

 

 

(A)

All persons selling or offering to sell dangerous drugs at retail or wholesale in Ohio must be licensed or registered with the Ohio state board of pharmacy as a dangerous drug distributor.

 

 

(B)

All dangerous drug distributors registered or licensed with the Ohio state board of pharmacy and who sell or offer to sell dangerous drugs at retail or wholesale on the "Internet" to persons located in Ohio or any other state must make such sales only in compliance with all state and federal laws governing the legal distri­bution of dangerous drugs.

 

 

(C)

"Internet" sites owned and/or maintained by Ohio registered or licensed danger­ous drug distribu­tors must provide the following information to the public on the "Internet" site and no drugs are to be shipped at wholesale or retail except in accordance with Ohio's drug laws:

 

 

(1)

Name dangerous drug distributor is licensed to do business as in Ohio.

 

 

(2)

Full address of licensed or registered site.

 

 

(3)

Name of responsible person as it appears on the dangerous drug distri­butor license.

 

 

(4)

Telephone number where responsible person may be contacted.

 

 

(5)

A list of the states in which the dangerous drug distributor may legally sell prescription drugs at wholesale or retail.

 

 

(6)

The name, address, and how the drug law enforcement agency may be con­tacted in each state in which the person is authorized to do business.  This may include a link to the drug law enforcement agency's "Internet" site and/or their e-mail address.

 

 

(D)

Any Ohio licensed or registered dangerous drug distributor requesting personal information from the public by way of the "Internet" site (questionnaire forms or e-mail) must provide for security and confidentiality of the information.  This portion of the "Internet" site must also provide infor­mation regarding how the personal information will be used, pursuant to all federal and state laws, rules, and regulations, and ensure that such information is not used for purposes not disclosed without the written informed consent of the patient or person submit­ting personal information.

 

 

4729-13-02  Procedure for state board of pharmacy approval as a laboratory.

 

 

(A)

A person, as defined in division (S) of section 4729.01 of the Revised Code, desir­ing to be approved by the state board of pharmacy as a laboratory shall file with the state board of phar­macy a completed application containing information relative to the qualifications for approval as set forth in rule 4729-13-03 of the Administrative Code.

 

 

(B)

The state board of pharmacy shall issue a terminal distributor of dangerous drugs license to purchase, possess, and utilize dangerous drugs for scientific and clini­cal purposes and for pur­poses of instruction at the establishment or place described in the application to each person who has submitted an appli­cation and has paid the required license fee if the board determines that such applicant meets the requirements set forth in this chapter.

 

 

(C)

All licenses issued pursuant to this rule shall be effective for a period of twelve months from the first day of January of each year.  A license shall be renewed by the state board of pharmacy for a like period, annually, according to the provi­sions of this rule, and the standard renewal procedure of sections 4745.01 to 4745.03 of the Revised Code.

 

 

(D)

The fee required for issuance of the license shall be the same as that required in section 4729.54 of the Revised Code.

 

 

(E)

A person desiring to renew the license shall submit a completed application for such renewal and pay the required fee on or before the fifteenth thirty-first day of December each year.

 

 

(F)

The state board of pharmacy, within thirty days after receipt of an applica­tion filed in the form and manner set forth in this rule for the issuance of a new or renewal license, shall notify the applicant whether or not such license will be issued or renewed.  If the board determines that such license will not be issued or renewed, such notice to the applicant shall set forth the reason or reasons that such license will not be issued or renewed.

 

 

4729-13-06  Responsible person for approved laboratories.

 

 

(A)

The responsible person whose name appears on the terminal distributor of dangerous drugs license shall sign such license and post the license in the establishment or place described in the license shall maintain such license in a readily available place in the principal location of such business.

 

 

(B)

The responsible person is responsible for maintaining adequate supervision and control over the dangerous drugs and controlled substances acquired, utilized, destroyed, or administered by the approved laboratory and main­tain­ing all records required by this chapter and federal law to be kept at the estab­lish­ment or place described in the license.

 

 

(C)

If there is a change in the responsible person, the board of pharmacy shall be notified within thirty days thereof of the date of change and the name of the new responsible person.

 

 

(1)

This notice to the board of pharmacy shall be made by completing, signing, and returning the form supplied by the board by certified mail, return receipt requested.

 

 

(2)

A complete inventory of the controlled substances on hand shall be taken, pursuant to federal regulations, with the new responsible person.  The new responsible person shall be responsible for this inventory.

 

 

4729-14-02  Procedure for licensure as an animal shelter.

 

 

(A)

A person, as defined in division (s) of section 4729.01 of the Revised Code, desir­ing to be licensed by the state board of pharmacy as an animal shelter shall file with the state board of pharmacy a completed application containing information relative to the qualifications for approval as set forth in rule 4729-14-03 of the Administrative Code.

 

 

(B)

The state board of pharmacy shall issue a limited terminal distributor of danger­ous drugs license, pursuant to sections 4729.531 and 4729.532 of the Revised Code, at the establishment or place described in the application to each person who has submitted an application and has paid the required license fee if the board determines that such applicant meets the re­quire­ments set forth in Chapter 4729-14 of the Administrative Code.

 

 

(C)

All licenses issued pursuant to this rule shall be effective for a period of twelve months from the first day of January of each year.  A license shall be renewed by the state board of pharmacy for a like period, annually, according to the provi­sions of this rule, and the standard renewal procedure of sections 4745.01 to 4745.03 of the Revised Code.

 

 

(D)

The fee required for issuance of the license shall be the same as that required in section 4729.54 of the Revised Code.

 

 

(E)

A person desiring to renew the license shall submit a completed application for such renewal and pay the required fee on or before the last thirty-first day of December each year.

 

 

(F)

The state board of pharmacy, within thirty days after receipt of a complete appli­cation filed in the form and manner set forth in this rule for the issuance of a new or renewal license, shall notify the applicant whether or not such license will be issued or renewed.  If the board determines that such license will not be issued or renewed, such notice to the applicant shall set forth the reason or reasons that such license will not be issued or renewed.

 

 

4729-14-05  Security controls for animal shelters.

 

 

(A)

Areas designated for the storage of dangerous drugs shall meet the security requirements in paragraph (B) of rule 4729-9-11 of the Administrative Code.

 

 

(B)

Controlled substances shall be stored in a securely locked, and substantially con­structed, stationary cabinet.

 

 

(C)

The responsible person shall notify the board of pharmacy and local law enforce­ment authorities of the theft or significant loss of any dangerous drug immedi­ately upon discovery of such theft or loss.  If the drug is a controlled substance, the responsible person shall also notify the regional office of the federal D.E.A. in his region pursuant to rule 4729-9-15 of the Administrative Code.

 

 

4729-14-06  Responsible person for an approved animal shelter.

 

 

(A)

An individual shall be the responsible person for no more than one such location except with writ­ten permission from the board.  A written request shall be sub­mitted outlining the circumstances requiring an individual to be re­spon­sible for more than one location and the period of time during which the circumstances will exist.  An individual shall not be designated the responsible person for a location unless that person shall be physically pre­sent in the facility a sufficient amount of time to provide supervision and control.

 

 

(B)

The responsible person whose name appears on the limited terminal distributor of dangerous drugs license shall sign such license and post the license in the establishment or place described in the license shall maintain such license in a readily available place in the principal location of the business.

 

 

(C)

The responsible person is responsible for maintaining adequate supervision and control over the dangerous drugs acquired, utilized, or administered by the approved animal shelter and is respon­sible for maintaining all required records.

 

 

(D)

If there is a change in the responsible person, the board of pharmacy shall be notified within thirty days thereof of the date of change and the name of the new responsible person.

 

 

(1)

This notice to the board of pharmacy shall be made by completing, sign­ing, and returning the form supplied by the board by certified mail, return receipt requested.

 

 

(2)

Included with this notice to the board shall be a notarized drug list prepared pursuant to paragraph (D) of rule 4729-14-03 of the Admini­strative Code.

 

 

(3)

A complete inventory of the controlled substances on hand shall be taken, pursuant to federal regulations, with the new responsible per­son.  The new responsible person shall be responsible for com­plet­ing and maintaining this inventory record at the site of the ter­mi­nal dis­tri­bu­tor of dangerous drugs.

 

 

4729-15-02  Responsibility for nuclear pharmacy.

 

A nuclear pharmacist shall maintain supervision and control of radiopharmaceuticals as provided in division (B) of section 4729.55 of the Revised Code.

 

 

(A)

The responsible nuclear pharmacist whose name appears on the terminal distri­butor of dangerous drugs license shall sign such license and post the license in the establishment or place described in the license shall maintain such license in a readily available place in the principal location of the business.

 

 

(B)

The responsible nuclear pharmacist is responsible for maintaining adequate supervision and con­trol over the dangerous drugs acquired and dispensed by the terminal distributor of dangerous drugs and maintaining all records required by this chapter and federal law to be kept at the estab­lishment or place described in the license.

 

 

(C)

If there is a change in the responsible nuclear pharmacist, the board of phar­macy shall be notified within thirty days thereof of the date of change and the name of the new responsible nuclear phar­macist.

 

 

(1)

This notice to the board of pharmacy shall be made by completing, sign­ing, and returning the form supplied by the board by certified mail, return receipt requested.

 

 

(2)

A complete inventory of the controlled substances on hand shall be taken, pursuant to federal regulations, with the new responsible nuclear pharma­cist.  The new responsible nuclear pharmacist shall be respon­sible for the accuracy of this inventory.

 

 

4729-19-02  Prescriptions for sterile products.

 

 

(A)

Sterile product prescriptions must meet the requirements of rule 4729-5-30 of the Administrative Code, except that a sterile product prescription prepared in accor­dance with federal and state requirements that is for a schedule II narcotic sub­stance to be compounded for the direct admini­stration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infu­sion may be trans­mitted by the prescriber or the prescriber’s agent to the dispensing pharmacy by facsimile.  The facsimile shall serve as the original written prescription and shall be received and maintained as in paragraphs (D) and (K) paragraph (F) of rule 4729-5-30 of the Administrative Code.  The ori­ginal signed prescription must remain with the patient’s records at the pre­scriber’s office or the institutional facility where it was issued.

 

 

(B)

The requirements for sterile product prescriptions received by a fluid therapy pharmacy are as specified in rule 4729-31-02 of the Administrative Code.

 

 

4729-31-03  Labeling.

 

When prepared in a fluid therapy pharmacy, no compounded parenteral product pre­scription may be dispensed unless a label is affixed to the container in which such drug is dispensed and such label includes:

 

 

(A)

The name and address of the pharmacy as it appears on the terminal dis­tri­bu­tor of dangerous drugs license;

 

 

(B)

The name of the patient for whom the drug is prescribed;

 

 

(C)

The name of the prescriber;

 

 

(D)

Directions for use of the drug which must include route of administration;

 

 

(E)

The date of dispensing;

 

 

(F)

Any cautions which may be required by federal or state law;

 

 

(G)

The name or initials of the pharmacist;

 

 

(H) (G)

The name and amount of the drug(s) added;

 

 

(I) (H)

The name and volume of the parenteral solution;

 

 

(J) (I)

The quantity of drug dispensed, if appropriate;

 

 

(K) (J)

Beyond use date;

 

 

(L) (K)

Storage conditions.

 

 

4729-33-01  Definitions.

 

As used in this chapter:

 

 

(A)

“Dangerous drug” has the same meaning as in section 4729.01 of the Revised Code.

 

 

(B)

“Controlled substance” has the same meaning as in section 4729.01 of the Revised Code.

 

 

(C)

“Terminal distributor of dangerous drugs” has the same meaning as in section 4729.01 of the Revised Code.

 

 

(D)

“Emergency medical service (EMS) organization” has the same meaning as in section 4765.01 of the Revised Code.

 

 

(E)

“Mutual aid” means a formal agreement between two or more EMS organi­za­tions to assist in emergency medical coverage in the other’s usual area of coverage including having access to dangerous drugs during the emergency situation.

 

 

(F)

“Posting up” means locating an EMS unit containing dangerous drugs at a location other than a location licensed by the board of pharmacy.

 

 

(G)

“Posting up at a special event” means locating an EMS unit containing danger­ous drugs at a location other than a location licensed by the board of phar­macy pursuant to a formal agreement with the sponsors of the special event.

 

 

(H)

“Special event” means an event requiring EMS coverage for more than twenty-four hours includ­ing, but not limited to, the following:

 

 

(1)

A county fair.

 

 

(2)

A weekend festival.

 

 

(I)

“Scope of practice” shall be as defined in section 4765.35 of the Revised Code and rule 4765-12-03 of the Administrative Code for a first responder, section 4765.37 of the Revised Code and rule 4765-15-04 of the Administrative Code for an emergency medical technician-basic, section 4765.38 of the Revised Code and rule 4765-16-04 of the Administrative Code for an emergency medical technician-intermediate, and section 4765.39 of the Revised Code and rule 4765-17-03 of the Administrative Code for an emergency medical technician-paramedic.

 

 

(J)

“Certification” “Certificate to practice” means the level to which an individual is trained and licensed as defined in section sections 4765.01 and 4765.30 of the Revised Code and rule 4765-1-01 of the Administrative Code.

 

 

(K)

“Medical director” has the same meaning as in rule 4765-10-06 of the Admini­strative Code.

 

 

(L)

“Responsible person” has the same meaning as in rule 4729-13-01 of the Admini­strative Code.

 

 

(M)

“Standing order” and “protocol” have the same meanings as in rule 4729-5-01 of the Administrative Code.

 

 

(N)

“Satellite” means an address licensed by the board as a terminal distributor of dangerous drugs that is separate from the licensed headquarters address of the EMS organization.

 

 

(O)

“Tamper-evident” means the package is sealed in such a way that access to the drugs stored within is not possible without leaving visible proof that such access has been attempted or made.

 

 

(P)

“Readily retrievable” means all records which are required to be maintained must be provided upon request to the inspector or agent of the board of phar­macy within three working days.

 

 

4729-33-02  Licensure.

 

 

(A)

Any emergency medical service (EMS) organization that desires to stock danger­ous drugs shall apply for and maintain a license as a terminal distributor of dan­gerous drugs.  The one location that serves as the main station will be deemed the headquarters location.  Any other locations associated with this headquarters where dangerous drugs will be stored will be licensed as “satellites”.  Only the headquarters location will be charged a license fee or renewal license fee.

 

 

(B)

Each location, headquarters and satellites, must be licensed as a limited terminal distributor of dangerous drugs and must maintain a current terminal distributor of dangerous drugs license and drug addendum.

 

 

(C)

An application for licensure must include all of the following:

 

 

(1)

A completed application;

 

 

(2)

A compilation of all protocols involving dangerous drugs that have been signed by the medical director and notarized;

 

 

(3)

A list of drugs referenced in the protocols to be stocked by the EMS organization, signed by the medical director and notarized;

 

 

(4)

A list of personnel employed by the EMS organization who may access and administer dangerous drugs, which includes the name of the indi­vidual, level of certification, their certification number, and expiration date;

 

 

(5)

A list of any and all formal mutual aid agreements with other EMS organi­za­tions;

 

 

(6)

The fee for the appropriate category of licensure.

 

 

(D)

Each location, headquarters and satellite, may only possess those dangerous drugs that are listed on the drug addendum and only at locations licensed by the board of pharmacy.

 

 

(1)

A medical director may add dangerous drugs to the drug list by sub­mit­ting revised, signed and notarized protocols and list of medi­ca­tions, and the addendum update fee.

 

 

(2)

A medical director may delete dangerous drugs from the drug list by sub­mitting a letter listing the drugs to be deleted.

 

 

(E)

A new application and fee is required prior to any change of location, addi­tion of a satellite loca­tion, change of category, name change, or change of own­er­ship.  These changes may be made during the annual renewal period with no additional fee other than the renewal fee.

 

 

(F)

The responsible person shall provide supervision and control of all locations where dangerous drugs are stored.  The responsible person must be a phy­si­cian licensed pursuant to Chapter 4731. of the Revised Code or a phar­ma­cist licensed pursuant to Chapter 4729. of the Revised Code.

 

 

(1)

To change the responsible person, the new responsible person must com­plete and return a notification of change of responsible person form within thirty days.

 

 

(2)

To change the medical director, the new medical director must submit a signed and notarized letter stating that he/she is accepting respon­sibility for the EMS organization.

 

 

(a)

If the new medical director approves of the current protocol and drug list, a signed and notarized letter must be submitted stating the current protocols and drug list on file have been reviewed and are approved by the medical director for use by this EMS organiza­tion, or

 

 

(b)

If the new medical director desires to change the protocols or drug list, the medical director must submit the revised, signed, and notarized protocols and drug list, and the adden­dum update fee.

 

 

(G)

Any changes in protocols that involve dangerous drugs must be submitted to the state board of pharmacy prior to the implementation of the protocols involved.  The state board of pharmacy may discuss such protocols with the state board of emer­gency medical services board, state medical board, or other governmental agencies as needed to assure their validity.

 

 

(H)

Any change of personnel requires a letter from the organization within thirty days of the change listing the type of change (addition, update, or deletion), names of the personnel involved, level of certification, their certification number, and expiration date.

 

 

4729-33-03  Security and storage of dangerous drugs.

 

 

(A)

Overall supervision and control of dangerous drugs is the responsibility of the responsible person.  The responsible person may delegate the day-to-day tasks to the emergency medical service (EMS) organization personnel who hold appro­priate certification to access the dangerous drugs for which they are responsible.

 

 

(B)

All dangerous drugs must be secured in a tamper-evident setting with access limited to EMS personnel based on their certification status except for sealed, tamper-evident solutions labeled for irrigation use.  All registrants shall provide effective and approved controls and procedures to deter and detect theft and diversion of dangerous drugs.

 

 

(C)

Only paramedics emergency medical technician-paramedics, emergency medical technician-intermediates, registered nurses, physicians, and phar­macists who are associated with that EMS organization may have access to any controlled sub­stances main­tained by the EMS organization.  Other persons employed by the EMS organization may have access to controlled substances only under the direct and immediate supervision of a paramedic an emergency medical technician-paramedic, an emergency medical technician-intermediate as defined in rules 4765-16-01 and 4765-16-02 of the Administrative Code, a registered nurse, or a physician in emergency situations.

 

 

(D)

Administration of dangerous drugs by an EMS employee personnel is limited to the scope of practice, as determined by the state board of emergency medical services board, for the individual’s certification level and the protocols as estab­lished by the medical director or when the individual is acting within their cer­tification level pursuant to direct prescriber’s orders received over an active com­muni­cation link.

 

 

(E)

All dangerous drugs will be maintained in a clean and temperature-controlled environment.

 

 

(F)

Any dangerous drug that reaches its expiration date is considered adulterated and must be separated from the active stock to prevent possible admini­stra­tion to patients.

 

 

(G)

Any non-controlled dangerous drug that is outdated may be returned to the sup­plier where the drug was obtained or may be disposed of in the proper manner.

 

 

(H)

Any controlled substance that is outdated may be returned to the supplier where the drug was obtained.

 

 

(I)

Destruction of outdated controlled substances may only be done by a state board of pharmacy agent or by prior written permission from the state board of phar­macy office.

 

 

(J)

Destruction of partially used controlled substances can be accomplished, with the appropriate documentation, by two licensed health care personnel, one of which must have at least a paramedic an emergency medical technician-intermediate, as defined in rules 4765-16-01 and 4765-16-02 of the Administrative Code, level of training.

 

 

(K)

Any loss or theft of dangerous drugs must be reported upon discovery, by telephone, to the state board of pharmacy, local law enforcement and, if con­trolled substances are involved, to the drug enforcement administration.  A report must be filed with the state board of pharmacy of any loss or theft of the vehicle or storage cabinets containing dangerous drugs used by the EMS organiza­tion.

 

 

(L)

Any dangerous drug showing evidence of damage or tampering shall be removed from stock and replaced immediately.

 

 

CHAPTER 4729-35  DRUG REPOSITORY PROGRAM

 

4729-35-01  Definitions.

 

As used in Chapter 4729-35 of the Administrative Code:

 

 

(A)

“Dangerous drug” has the same meaning as in section 4729.01 of the Revised Code and in rule 4729-9-01 of the Administrative Code.

 

 

(B)

“Drug repository program” has the same meaning as in sections 3715.87 to 3715.873 of the Revised Code.

 

 

(C)

“Hospital” has the same meaning as in section 3715.87 of the Revised Code.

 

 

(D)

“Institutional facility” has the same meaning as in rule 4729-17-01 of the Admini­strative Code.

 

 

(E)

“Licensed health care professional” has the same meaning as in section 3715.872 of the Revised Code.

 

 

(F)

“Nonprofit clinic” has the same meaning as in section 3715.87 of the Revised Code.

 

 

(G)

“Original sealed and tamper-evident unit dose packaging” includes single unit dose packaging of oral medications from a manufacturer or a repackager licensed with the Federal Food and Drug Administration, and injectables, topicals, and aerosols in the manufacturer’s or repackager’s unopened original tamper-evident packaging.

 

 

4729-35-02  Eligibility requirements for a pharmacy, hospital, or nonprofit clinic.

 

A pharmacy, hospital, or nonprofit clinic may elect to participate in the drug repository program, pursuant to sections 3715.87 to 3715.873 of the Revised Code, if all of the following requirements are met:

 

 

(A)

Must be licensed as a terminal distributor of dangerous drugs pursuant to section 4729.54 of the Revised Code.

 

 

(B)

Must comply with all federal and state laws, rules, and regulations.

 

 

4729-35-03  Donating drugs.

 

 

(A)

The following may donate a dangerous drug, pursuant to the eligibility require­ments of rule 4729-35-04 of the Administrative Code, to a pharmacy, hospital, or nonprofit clinic that elects to participate in the drug repository program:

 

 

(1)

A licensed terminal distributor of dangerous drugs.

 

 

(2)

A licensed wholesale distributor of dangerous drugs.

 

 

(3)

A person who was legally dispensed a dangerous drug pursuant to a patient-specific drug order.

 

 

(B)

A person electing to donate an eligible dangerous drug shall not have taken custody of the drug prior to the donation.  The person may direct the donation through a terminal distributor of dangerous drugs.

 

 

(C)

A person who resides in an institutional facility and was legally dispensed a dangerous drug pursuant to a patient-specific order may elect to sign and date a donor form prior to donating a drug, which shall state “from this day forward I wish to donate all my remaining unused drugs that are eligible, pursuant to rule 4729-35-04 of the Administrative Code, to the drug repository program”.

 

 

(D)

A person designated by durable power of attorney, a guardian, or other individual responsible for the care and well-being of a patient may make the decision to donate an eligible dangerous drug.

 

 

4729-35-04  Eligible drugs.

 

All dangerous drugs, except controlled substances and drug samples, may be donated to a pharmacy, hospital, or nonprofit clinic that elects to participate in the drug repository pro­gram if the drugs meet all of the following requirements:

 

 

(A)

The drugs are in their original sealed and tamper-evident unit dose packaging.  The packaging must be unopened except that the drugs packaged in single unit doses may be accepted and dispensed when the outside packaging is opened if the single unit dose packaging is undisturbed.

 

 

(B)

The drugs have been in the possession of a licensed healthcare professional and not in the possession of the ultimate user.

 

 

(C)

The drugs have been stored according to Federal Food and Drug Administration storage requirements.

 

 

(D)

The drugs must have an expiration date of six months or greater.

 

 

(E)

The packaging must list the lot number and expiration date of the drug.

 

 

(F)

The drugs must not have any physical signs of tampering or adulteration.

 

 

(G)

The drug packaging must not have any physical signs of tampering.

 

 

4729-35-05  Eligibility requirements to receive drugs.

 

A pharmacy, hospital, or nonprofit clinic that elects to participate in the drug repository program must determine if a person is eligible to receive drugs.  A person must meet the following requirements to become an eligible recipient of drugs from the drug repository program:

 

 

(A)

Is a resident of Ohio, and

 

 

(B)    (1)

Has no active third party prescription drug reimbursement coverage for the drug prescribed; or,

 

 

(2)

Is a patient of a nonprofit clinic.

 

 

4729-35-06  Donor forms.

 

 

(A)

Each donor must sign a form stating that the donor is the owner of the drug and intends to voluntarily donate the drug to the drug repository program.  The donor form must be completed prior to any donation and include at least the following:

 

 

(1)

The name of the person that was originally dispensed the drugs, or the name of the terminal distributor of dangerous drugs or wholesale distri­butor of dangerous drugs that owns the drugs.

 

 

(2)

The signature of the donor, which may include the person designated by durable power of attorney, a guardian, an individual responsible for the care and well-being of a patient, or the signature of the responsible person or his/her designee from a terminal distributor of dangerous drugs or a wholesale distributor of dangerous drugs.

 

 

(3)

The date the form was signed.

 

 

(B)

The following donor information must also be documented.  This information may be documented on the original signed donor form or on an alternate record.  If an alternate record is used, the record must include the name of the donor in addition to the required information in this paragraph.

 

 

(1)

The brand name of the drug donated, or the generic name and list either the name of the manufacturer or the national drug code number (NDC#).

 

 

(2)

The strength of the drug donated.

 

 

(3)

The quantity of the drug donated.

 

 

(4)

The date the drug was donated.

 

 

4729-35-07  Recipient forms.

 

Each recipient of a donated drug from the drug repository program must sign a form stating they understand the immunity provisions of the program pursuant to paragraph (B) of section 3715.872 of the Revised Code.  The recipient form must also include at least the following:

 

 

(A)

The signature of the recipient of the donated drug.

 

 

(B)

The date the form was signed by the recipient.

 

 

(C)

The brand name of the drug received, or the generic name and list either the name of the manufacturer or the national drug code number (NDC#).

 

 

(D)

The strength of the drug received by the recipient.

 

 

(E)

The quantity of the drug received by the recipient.

 

 

4729-35-08  Recordkeeping.

 

 

(A)

Donor forms must be maintained for a minimum of three years by a terminal distributor of dangerous drugs, a wholesale distributor of dangerous drugs, or an institutional facility.

 

 

(B)

Recipient forms must be maintained for a minimum of three years by a pharmacy, hospital, or nonprofit clinic.

 

 

(C)

An invoice must be created by the donor location, which includes a terminal dis­tributor of dangerous drugs, a wholesale distributor of dangerous drugs, or an institutional facility where the donor resides.  The invoice must include at least the following information:

 

 

(1)

The name and address of the donor location.

 

 

(2)

The brand name of the drug donated, or the generic name and list either the name of the manufacturer or the national drug code number (NDC#).

 

 

(3)

The strength of the drug.

 

 

(4)

The quantity of the drug.

 

 

(5)

The lot number of the drug.

 

 

(6)

The expiration of the drug.

 

 

(7)

The date the drug was sent to a pharmacy, hospital, or nonprofit clinic.

 

 

(8)

The name and address of the recipient pharmacy, hospital, or nonprofit clinic.

 

 

(D)

A copy of the invoice must be maintained for a minimum of three years by both the donor location, which includes a terminal distributor of dangerous drugs, a wholesale distributor of dangerous drugs, or an institutional facility, and the recipient location, which includes a pharmacy, hospital, or nonprofit clinic.

 

 

4729-35-09  Handling fees.

 

A pharmacy, a hospital, or a nonprofit clinic may charge the recipient of a donated drug a maximum of 200% of the Medicaid professional dispensing fee to cover restocking and dispensing costs.

 

 

Mr. Braylock reported that there had been no meeting of the Nursing Board’s Committee on Prescriptive Governance since his last report.

 

Mr. Keeley then discussed his Legislative Report with the Board.

 

R-2004-094

Mr. McMillen presented a request for approval as an In-State Provider of Continuing Pharmacy Education from Parma Community General Hospital Pharmacy Department.  After discussion, Mrs. Gregg moved that the approval be granted.  The motion was seconded by Ms. Eastman and approved by the Board (Aye-7/Nay-0).

 

R-2004-095

Mr. McMillen then presented a request for approval as an In-State Provider of Continuing Pharmacy Education from Specialized Pharmacy Education.  After discussion, Mr. Turner moved that the approval be granted.  The motion was seconded by Ms. Eastman and approved by the Board (Aye-7/Nay-0).

 

R-2004-096

Mr. Benedict then presented a request from Woodrow Weinstein, R.Ph. asking for a waiver from the requirements of Rule 4729-5-11(A) to allow him to serve as responsible pharmacist at more than one location.  After discussion, Mrs. Adelman moved that the request be approved for a one-year time period for the following two licenses:

 

Elmwood Place Pharmacy (02-0149650)

Elmwood Institutional Pharmacy (02-0917250)

 

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

 

R-2004-097

Mr. Benedict next presented a request from Kaiser Foundation Health Plan Pharmacy for approval as a central fill location for satellite Kaiser facilities.  After discussion, Mr. Braylock moved that the Board approve the request.  The motion was seconded by Mr. Turner and approved by the Board (Aye-7/Nay-0).

 

There was no Medical Board Prescribing Committee report.

 

Due to his planned absence for business reasons on Tuesday, December 9, 2003, and Vice-President Kost’s absence for business reasons, President Giacalone appointed Board member Diane Adelman to serve as Presiding Officer for the Board meeting on that day.

 

The Board discussed the possibility of holding a meeting at an outside site, such as a college of pharmacy.  Staff was instructed to investigate the feasibility and report back to the Board.

  3:28 p.m.

 

Mrs. Gregg 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 pursuant to Section 121.22(G)(1) of the Revised Code.  The motion was seconded by Mrs. Adelman and a roll call vote was conducted by Presi­dent Giacalone as follows: Adelman-Yes, Braylock-Yes, Eastman-Yes, Gregg-Yes, Lipsyc-Yes, Teater-Yes, and Turner-Yes.

  4:35 p.m.

 

The Executive Session ended.  The Board meeting recessed until Tuesday, December 9, 2003.

 

 

TUESDAY, december 9, 2003

 

  8:35 a.m.

ROLL CALL

 

 

The State Board of Pharmacy convened in Room East-B, 31st Floor, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio with the following members present:

 

Diane C. Adelman, R.Ph. (Presiding Officer); Gregory Braylock, R.Ph.; Suzanne R. Eastman, R.Ph.; Elizabeth I. Gregg, R.Ph.; Nathan S. Lipsyc, R.Ph.; Dorothy S. Teater, Public Mem­ber; and James E. Turner, R.Ph.

 

Mr. Braylock and Mr. Benedict presented the Probation Report.  There were no issues requiring official action of the Board.

 

R-2004-098

The Board considered a request from Amicore for approval of their electronic prescribing program.  After discussion, Mrs. Gregg moved that the Board consider the Amicore system to be approvable pending final inspection of the installed product.  The motion was seconded by Mr. Braylock and approved by the Board (Aye-7/Nay-0).

 

R-2004-099

Following discussion of conflicting schedules, the Board agreed to move the June 2004 Board meeting to June 21, 22, 23, 2004.

  9:06 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 Curtis Lee Hull, R.Ph., Hilliard.

10:32 a.m.

 

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

10:46 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 Fumiyo Shida Witt, R.Ph., Brunswick.

12:03 p.m.

 

The hearing ended and the record was closed.

 

R-2004-100

Mr. Winsley presented a request from St. Vincent Charity Hospital Pharmacy for approval as a central fill pharmacy so that prescriptions received at St. John Westshore Hospital could be filled at St. Vincent’s Pharmacy and returned to St. John’s Pharmacy for patient pickup.  After discussion, Mr. Braylock moved that the Board approve the request.  The motion was seconded by Mrs. Gregg and approved by the Board (Aye-7/Nay-0).

12:15 p.m.

 

The Board recessed for lunch.

  1:30 p.m.

 

The Board convened in Room South-A, 31st Floor, 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:

 

Diane C. Adelman, R.Ph. (Presiding Officer); Gregory Braylock, R.Ph.; Suzanne R. Eastman, R.Ph.; Elizabeth I. Gregg, R.Ph.; Nathan S. Lipsyc, R.Ph.; Dorothy S. Teater, Public Mem­ber; and James E. Turner, R.Ph.

 

R-2004-101

Following presentations by Board members and self-introductions by the candidates for licensure by reciprocity, the following candidates participated in a discussion of phar­macy laws and rules with Mr. McMillen and were then presented with their pharmacist identification cards.

 

KATHLEEN LOUISE BAKER

03-1-26022

TEXAS

STEVEN DAVID BAKER

03-1-26023

TEXAS

MUHAMMAD ABDUL BARI

03-1-26020

MICHIGAN

LISHUNDA MARIE FRANKLIN

03-1-26010

LOUISIANA

JEREMY ROBERT HOVEN

03-1-25999

MICHIGAN

SHANNON MARIE HOVEN

03-1-25998

MICHIGAN

JEFFREY RICHARD LOONEY

03-1-25929

WEST VIRGINIA

KIMBERLY ANN LUTZ

03-1-26001

NORTH DAKOTA

JASON PAUL MARTIN

03-1-26019

WEST VIRGINIA

JINI PAUL MATTAM

03-1-26006

PENNSYLVANIA

GERALDINE S. MORROW HARRIS

03-1-25992

LOUISIANA

DONNA KATHRYN SPENCER

03-1-26014

ARKANSAS

NANCY BARNHART SPRINGER

03-1-26013

VIRGINIA

  1:49 p.m.

 

The Board reconvened in Room East-B with all members present.  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 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 Mrs. Gregg and a roll call vote was conducted by Presiding Officer Adelman as follows: Braylock-Yes, Eastman-Yes, Gregg-Yes, Lipsyc-Yes, Teater-Yes, and Turner-Yes.

  2:40 p.m.

R-2004-102

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 Curtis Lee Hull, R.Ph.:

 

 

 

ORDER OF THE STATE BOARD OF PHARMACY

(Docket No. D-030117-058)

 

In The Matter Of:

 

CURTIS LEE HULL, R.Ph.

5066 Silver Bow Drive

Hilliard, Ohio 43026

(R.Ph. No. 03-2-10277)

 

 

 

 

INTRODUCTION

 

THE MATTER OF CURTIS LEE HULL CAME FOR HEARING ON DECEMBER 9, 2003, BEFORE THE FOLLOWING MEMBERS OF THE BOARD; DIANE C. ADELMAN, R.Ph., (presiding officer); GREGORY BRAYLOCK, R.Ph.; SUZANNE R. EASTMAN, R.Ph.; ELIZABETH I. GREGG, R.Ph.; NATHAN S. LIPSYC, R.Ph.; DOROTHY S. TEATER, PUBLIC MEMBER; AND JAMES E. TURNER, R.Ph.

 

CURTIS LEE HULL WAS REPRESENTED BY DANIEL K. FRIEND AND THE STATE OF OHIO WAS REPRESENTED BY SALLY ANN STEUK, ASSISTANT ATTORNEY GENERAL.

 

 

 

 

SUMMARY OF EVIDENCE

State’s Witnesses

 

1.  Christopher Reed, Ohio State Board of Pharmacy

 

Respondent's Witnesses

 

1.  Curtis Lee Hull, R.Ph., Respondent

 

 

 

 

State's Exhibits

 

1.  Copy of Summary Suspension Order/Notice of Opportunity For Hearing letter  [01-17-03]

1A-1G.  Procedurals

1H.  Copy of Addendum Notice  [10-27-03]

2.  Notarized Statement of Curtis Lee Hull  [01-07-03]

3.  Drug Audit Accountability Report for Methylphenidate 5mg tablets at The Medicine Shoppe  [01-07-03]

4.  Copy of State Board of Pharmacy Order in re Curtis L. Hull  [10-30-80]

4A.  Copy of Quarterly Progress Report from Curtis Lee Hull  [08-11-81]

4B.  Copy of Quarterly Progress Report from Curtis Lee Hull  [08-02-82]

4C.  Copy of Quarterly Progress Report from Curtis Lee Hull  [11-01-82]

5.  Copy of State Board of Pharmacy Order in re Curtis Lee Hull, R.Ph.  [11-04-91]

5A.  Copy of PRO Impaired Pharmacist’s Contract for Curtis Hull  [06-23-88]

5B.  Copy of Shepherd Hill Hospital Outpatient Recovery Plan for Curtis Lee Hull, R.Ph.  [10-11-88]

5C.  Copy of Shepherd Hill Hospital Outpatient Relapse Prevention Contract for Curtis Lee Hull, R.Ph.  [10-11-88]

6.  Indictment, State of Ohio vs. Curtis L. Hull, Case No. 03CR 04-2913, Franklin County Common Pleas Court  [04-30-03]

7.  Entry of Guilty Plea  [07-24-03]

8.  Judgment Entry  [07-24-03]

 

 

 

 

Respondent's Exhibits

 

A.   Copy of Netcare Assessment of Curtis Lee Hull  [05-08-03]

B.   Copy of Columbus Health Department Alcohol and Drug Abuse Outpatient Treatment Program records for Curtis Lee Hull  [05-13-03 to 08-11-03]

C.   PRO Pharmacist’s Recovery Contract for Curtis Hull  [09-20-03]

D.  Support Group Attendance Records  [01-08-03 to 12-05-03]

E.   Drug Screen Reports  [05-21-03, 06-10-03, and 07-25-03]

F.   Disposition Sheet, State of Ohio vs. Curtis L. Hull, Case No.  03CR2913, Franklin County Common Pleas Court  [07-22-03]

G.   Notice of Community Control Imposed  [07-22-03]

H.   Franklin County Adult Probation Services Report for Curtis Hull  [not dated]

I-K. Three Letters of Support  [03-13-03 to 12-07-03]

 

 

 

 

FINDINGS OF FACT

 

After having heard the testimony, observed the demeanor of the witnesses, considered the evidence, and weighed the credibility of each, the State Board of Pharmacy finds the follow­ing to be fact:

 

 

 

 

(1)  Records of the Board of Pharmacy indicate that Curtis Lee Hull was originally licensed by the State of Ohio as a pharmacist on July 20, 1972, pursuant to exami­nation, and that his license to practice pharmacy in Ohio was summarily suspended effective January 17, 2003.  Records further reflect that effective July 9, 2002, Curtis Lee Hull was the Responsible Pharmacist at The Medicine Shoppe pursuant to Sections 4729.27 and 4729.55 of the Ohio Revised Code and Section 4729-5-11 of the Ohio Administrative Code.  Records further reflect that Curtis Lee Hull was pre­viously disciplined by the Board on October 30, 1980, and November 4, 1991.

 

(2)  Curtis Lee Hull is addicted to or abusing liquor or drugs and/or impaired physi­cally or mentally to such a degree as to render him unfit to practice pharmacy within the meaning of Section 4729.16(A)(3) of the Ohio Revised Code, to wit: Curtis Lee Hull has admitted to being addicted to alcohol and to stealing and abus­ing controlled sub­stances to counteract the sedative effects of alcohol.  Curtis Lee Hull has admitted to Board agents that he consumes approximately 5 to 10 mg of methylphenidate per day on the weekdays, and 15 to 20 mg per day on weekends.  Such conduct indicates that Curtis Lee Hull falls within the ambit of Sections 3719.121(A)&(B) and 4729.16(A)(3) of the Ohio Revised Code.

 

(3)  Curtis Lee Hull did, from July 8, 2002, through January 7, 2003, with purpose to deprive, knowingly obtain or exert control over dangerous drugs, the property of The Medicine Shoppe, beyond the express or implied consent of the owner, to wit: Curtis Lee Hull has admittedly stolen 473 unit doses of methylphenidate 5 mg for his personal abuse.  Such conduct is in violation of Section 2913.02 of the Ohio Revised Code.

 

(4)  Curtis Lee Hull pled guilty, on or about July 22, 2003, to one (1) count of Theft, a felony of the fourth degree under Section 2913.02 of the Ohio Revised Code.  State of Ohio vs. Curtis L. Hull, Case No. 03CR04-2913, Franklin County Common Pleas Court.

 

 

 

 

CONCLUSIONS OF LAW

 

 

 

 

(1)  The State Board of Pharmacy concludes that paragraphs (2) through (4) of the Findings of Fact constitutes being guilty of a felony and gross immorality as pro­vided in Division (A)(1) of Section 4729.16 of the Ohio Revised Code.

 

(2)  The State Board of Pharmacy concludes that paragraphs (2) through (4) of the Findings of Fact constitute being guilty of dishonesty and unprofessional conduct in the practice of pharmacy as provided in Division (A)(2) of Section 4729.16 of the Ohio Revised Code.

 

(3)  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)  The State Board of Pharmacy concludes that paragraph (2) of the Findings of Fact constitute being guilty of willfully violating, conspiring to violate, attempting to violate, or aiding and abetting the violation of provisions of Chapter 3719. and 4729. of the Revised Code as provided in Division (A)(5) of Section 4729.16 of the Ohio Revised Code.

 

 

 

 

DECISION OF THE BOARD

 

Pursuant to Section 3719.121 of the Ohio Revised Code, the State Board of Pharmacy hereby removes the Summary Suspension Order issued to Curtis Lee Hull on January 17, 2003.

 

Pursuant to Section 4729.16 of the Ohio Revised Code, and after consideration of the record as a whole, the State Board of Pharmacy adjudicates the matter of Curtis Lee Hull as follows:

 

 

 

 

(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 permanently the pharmacist identifica­tion card, No. 03-2-10277, held by Curtis Lee Hull 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 permanently the pharmacist identifica­tion card, No. 03-2-10277, held by Curtis Lee Hull 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 permanently the pharmacist identifica­tion card, No. 03-2-10277, held by Curtis Lee Hull effective as of the date of the mail­ing of this Order.

 

(D)  On the basis of the Findings of Fact and paragraph (4) of the Conclusions of Law set forth above, the State Board of Pharmacy hereby revokes permanently the pharmacist identifica­tion card, No. 03-2-10277, held by Curtis Lee Hull effective as of the date of the mail­ing of this Order.

 

 

 

 

Pursuant to Section 4729.16(B) of the Ohio Revised Code, Curtis Lee Hull must return his 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.

 

THIS ORDER WAS APPROVED BY A VOTE OF THE STATE BOARD OF PHARMACY.

MOTION CARRIED.

SO ORDERED.

 

 

 

The motion was seconded by Mrs. Gregg and approved by the Board (Aye-6/Nay-1).

 

R-2004-103

Mr. Braylock then moved that the Board adopt the following Order in the matter of Fumiyo Shida Witt, R.Ph.:

 

 

 

ORDER OF THE STATE BOARD OF PHARMACY

(Docket No. D-020912-013)

 

In The Matter Of:

 

FUMIYO SHIDA WITT, R.Ph.

4239 Shalbey Trail

Brunswick, Ohio 44212

(R.Ph. No. 03-3-24194)

 

 

 

 

INTRODUCTION

 

THE MATTER OF FUMIYO SHIDA WITT CAME FOR HEARING ON DECEMBER 9, 2003, BEFORE THE FOLLOWING MEMBERS OF THE BOARD: DIANE C. ADELMAN, R.Ph. (presiding officer); GREGORY BRAYLOCK, R.Ph.; SUZANNE R. EASTMAN, R.Ph.; ELIZABETH I. GREGG, R.Ph.; NATHAN S. LIPSYC, R.Ph.; DOROTHY S. TEATER, PUBLIC MEMBER; AND JAMES E. TURNER, R.Ph.

 

FUMIYO SHIDA WITT WAS REPRESENTED BY RALPH E. BREITFELLER AND THE STATE OF OHIO WAS REPRESENTED BY SALLY ANN STEUK, ASSISTANT ATTORNEY GENERAL.

 

 

 

 

SUMMARY OF EVIDENCE

State’s Witnesses

 

1.  Lynn Mudra, State Board of Pharmacy

 

Respondent's Witnesses

 

1.  Fumiyo Shida Witt, R.Ph., Respondent

 

State's Exhibits

 

1.  Copy of Notice of Opportunity For Hearing letter  [09-12-02]

1A-1G.  Procedurals

2.  Rx #C205127  [07-20-01]

2A.  Copy of Cleveland Ohio Police Divisional Information Report of Detective Greg Whitney [03-07-02 to 03-12-02]

3.  Rx #C209006  [09-13-01]

 

Respondent's Exhibits

 

A.  Resume of Fumiyo Witt

 

 

 

 

FINDINGS OF FACT

 

After having heard the testimony, observed the demeanor of the witnesses, considered the evidence, and weighed the credibility of each, the State Board of Pharmacy finds the follow­ing to be fact:

 

 

 

 

(1)  Records of the Board of Pharmacy indicate that Fumiyo Shida Witt was originally licensed by the State of Ohio as a pharmacist on July 14, 2000, pursuant to exami­nation, and is cur­rently licensed to practice pharmacy in Ohio.  Records further reflect, dur­ing the relevant time periods stated herein, Fumiyo Shida Witt was the Responsible Pharmacist at Marc’s Pharmacy pursuant to Sections 4729.27 and 4729.55 of the Ohio Revised Code and Rule 4729-5-11 of the Ohio Administrative Code.

 

(2)  Fumiyo Shida Witt did, on or about July 18, 2001, knowingly sell a controlled sub­stance when such conduct was not in accordance with Chapters 3719., 4729., and 4731. of the Ohio Revised Code, to wit: when presented with prescription #C205127 that had obviously been forged, Fumiyo Shida Witt dispensed 60 Vicodin tablets that were not prescribed.  The drug written on the prescription was "Vikadon".  Such con­duct is in violation of Section 2925.03(A) of the Ohio Revised Code.

 

(3)  Fumiyo Shida Witt did, on or about July 18, 2001, knowingly possess a false or forged prescription, to wit: when presented with prescription #C205127 that had ob­viously been forged, Fumiyo Shida Witt dispensed 60 Vicodin tablets that were not prescribed, and Fumiyo Shida Witt filed the prescription in the pharmacy records.  The patient had written "Vikadon" on the prescription.  Such conduct is in violation of Sec­tion 2925.23(B) of the Ohio Revised Code.

 

(4)  Fumiyo Shida Witt did, on or about September 13, 2001, knowingly sell a con­trolled substance when such conduct was not in accordance with Chapters 3719., 4729., and 4731. of the Ohio Revised Code, to wit: when presented with prescrip­tion #C209006 that had obviously been forged, Fumiyo Shida Witt dispensed 60 hydroco­done 5 mg with acetaminophen 500 mg tablets when 15 had been pre­scribed.  The patient had altered the numeric quantity from 15 to 60, in a different-colored ink, yet the alphabetically written quantity was not altered on the prescrip­tion.  Such conduct is in violation of Section 2925.03(A) of the Ohio Revised Code.

 

(5)  Fumiyo Shida Witt did, on or about September 13, 2001, knowingly possess a false or forged prescription, to wit: when presented with prescription #C209006 that had obviously been forged, Fumiyo Shida Witt dispensed 60 hydrocodone 5 mg with Acetaminophen 500 mg tablets when 15 had been prescribed.  The patient had altered the numeric quantity from 15 to 60, in a different-colored ink, yet the alpha­betically written quantity was not altered on the prescription.  Fumiyo Shida Witt filed the pre­scription in the pharmacy records.  Such conduct is in violation of Sec­tion 2925.23(B) of the Ohio Revised Code.

 

 

 

 

CONCLUSIONS OF LAW

 

(1)  The State Board of Pharmacy concludes that paragraphs (2) through (5) of the Findings of Fact constitute being guilty of unprofessional conduct in the practice of pharmacy as provided in Division (A)(2) of Section 4729.16 of the Ohio Revised Code.

 

(2)  The State Board of Pharmacy concludes that paragraphs (2) through (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.

 

 

 

 

DECISION OF THE BOARD

 

Pursuant to Section 4729.16 of the Ohio Revised Code, and after consideration of the record as a whole, the State Board of Pharmacy adjudicates the matter of Fumiyo Shida Witt as fol­lows:

 

 

 

 

(A)  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 imposes a monetary pen­alty of one thousand dollars ($1000.00) on Fumiyo Shida Witt and payment of the monetary penalty is due and owing within thirty days of the mailing of this Order.  The remit­tance should be made payable to the "Treasurer, State of Ohio" and mailed with the enclosed form to the State Board of Pharmacy, 77 South High Street, Room 1702, Columbus, Ohio 43215-6126.

 

(B)  On the basis of the Findings of Fact and paragraph (1) of the Conclusions of Law set forth above, the State Board of Pharmacy hereby places Fumiyo Shida Witt on probation for one year from the effective date of this Order with the following con­ditions:

 

 

 

 

(1)  Fumiyo Shida Witt must personally attend a live program, within one year after the effective date of this Order, of at least three hours (0.3 CEUs) of Board-approved continuing pharmacy education in Jurisprudence.  Docu­mentation must be submitted to the Board office within sixty days of suc­cessful completion.

 

(2)  Fumiyo Shida Witt must not violate the drug laws of the state of Ohio, any other state, or the federal government.

 

(3)  Fumiyo Shida Witt must abide by the rules of the State Board of Phar­macy.

 

(4)  Fumiyo Shida Witt must comply with the terms of this Order.

 

 

 

 

Fumiyo Shida Witt is hereby advised that the Board may at any time revoke proba­tion for cause, modify the conditions of probation, and reduce or extend the period of pro­bation.  At any time during this period of probation, the Board may revoke probation for a violation occurring during the probation period.

 

 

 

 

THIS ORDER WAS APPROVED BY A VOTE OF THE STATE BOARD OF PHARMACY.

MOTION CARRIED.

SO ORDERED.

 

 

 

The motion was seconded by Mrs. Teater and approved by the Board (Aye-6/Nay-1).

 

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

  2:57 p.m.

 

Mrs. Gregg moved that the Board receive Per Diem as follows:

 

PER DIEM

12/8

12/9

Total

Adelman

1

1

2

Braylock

1

1

2

Eastman

1

1

2

Giacalone

1

-

1

Gregg

1

1

2

Kost

-

-

0

Lipsyc

1

1

2

Teater

1

1

2

Turner

1

1

2

 

 

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

  2:58 p.m.

 

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

 

 

THE BOARD APPROVED THESE MINUTES

JANUARY 6, 2004