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                        Eml:  exec@bop.state.oh.us

 

 

 

Minutes Of The Meeting

Ohio State Board of Pharmacy

July 14 & 15, 2003

 

MONDAY, JULY 14, 2003

 

  8:07 a.m.

ROLL CALL

 

 

The State Board of Pharmacy convened in the Starboard Room at Maumee Bay Confer­ence Center, 1750 Park Road #2, Oregon, Ohio with the following members present:

 

Robert P. Giacalone, R.Ph. (President); Lawrence J. Kost, R.Ph. (Vice-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.

 

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

  8:10 a.m.

 

As the first order of business, Immediate Past President Diane C. Adelman, R.Ph. admini­stered the following oaths of office to President Robert P. Giacalone, R.Ph. and Vice-President Lawrence J. Kost, R.Ph.:

 

 

OATH  OF PRESIDENT

I, ROBERT P. GIACALONE, as President of the Ohio Board of Pharmacy do solemnly swear to uphold the Constitution of the United States and the state of Ohio; to impar­tially enforce the laws governing the profession of pharmacy and the legal distribution of drugs in the state of Ohio; and carry out the responsibilities of the Board as mandated by the laws of the state of Ohio without bias or prejudice, so help me God.

 

 

OATH  OF  VICE-PRESIDENT

I, LAWRENCE J. KOST, as Vice-President of the Ohio Board of Pharmacy do solemnly swear to uphold the Constitution of the United States and the state of Ohio; to impar­tially enforce the laws governing the profession of pharmacy and the legal distribution of drugs in the state of Ohio; and carry out the responsibilities of the Board as mandated by the laws of the state of Ohio without bias or prejudice, so help me God.

 

R-2004-001

Mr. McMillen distributed the following list of reciprocity candidates who participated in a discussion of pharmacy laws and rules with Mr. McMillen on July 10, 2003 and were then presented with their pharmacist identification cards:

 

AMANDA JO COLLINGSWORTH

03-3-25884

ILLINOIS

JEFFREY ALAN FENERTY

03-3-25825

PENNSYLVANIA

DINA R. GIRGIS

03-3-25847

NEW YORK

TRAMY THUY LENGUYEN

03-3-25826

TEXAS

MICHAEL DAVID MARTIN, JR.

03-3-25719

ARIZONA

KENNETH JAY MAXIK

03-3-25757

NEW YORK

BRADLEY EDWARD McCRORY

03-3-25894

INDIANA

CHRISTINE  MYERS HARRIS

03-3-25860

WEST VIRGINIA

JAY WESLEY MYERS

03-3-25861

WEST VIRGINIA

DAVID JUDE PAVLIK

03-3-25908

PENNSYLVANIA

SABRINA JOY RAYBON

03-3-25917

MARYLAND

SHELBY MARIE SCRABIS

03-3-25864

NORTH CAROLINA

CHRISTOPHER JAMES SUGG

03-3-25875

NORTH CAROLINA

 

R-2004-002

President Giacalone then distributed the following list of committee assignments to the Board members along with a revised seating chart for Fiscal Year 2004:

 

 

Adelman           Exams/Internship/Reciprocity

Braylock           Administration/Probationary Reports

Eastman            Personnel

Giacalone         Compliance/Enforcement

Gregg               Continuing Education

Kost                 Legislation/Rules

Lipsyc               Licensure/Registration

Teater               Budget/Finance

Turner               Consumer Affairs/Public Relations

 

 

Mr. Rowland announced that the following settlement agreements had been signed by all parties and were now effective:

 

R-2004-003

SETTLEMENT AGREEMENT WITH THE STATE BOARD OF PHARMACY

(Docket No. D-030422-069)

 

In The Matter Of:

 

RAYNER B. LOTTON, R.Ph.

505 Sycamore Drive

Circleville, Ohio 43113

(R.Ph. No. 03-3-22200)

 

 

This Settlement Agreement is entered into by and between Rayner B. Lotton 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.

 

Rayner B. Lotton voluntarily enters into this Agreement being fully informed of his rights afforded under Chapter 119. of the Ohio Revised Code, including the right to rep­re­sentation by counsel, the right to a formal adjudication hearing on the issues con­tained herein, and the right to appeal.  Rayner B. Lotton acknowledges that by enter­ing into this agreement he has waived his rights 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, Rayner B. Lotton is licensed to practice pharmacy in the State of Ohio.

 

 

Whereas, on or about April 22, 2003, pursuant to Chapter 119. of the Ohio Revised Code, Rayner B. Lotton was notified of the allegations or charges against him, his right to a hearing, his rights in such hearing, and his right to submit contentions in writing.  Rayner B. Lotton requested a hearing; it was scheduled.  The April 22, 2003, Notice of Oppor­tunity for Hearing contains the following allegations or charges:

 

 

(1)

Records of the Board of Pharmacy indicate that Rayner B. Lotton was originally licensed in the State of Ohio on March 4, 1997, pursuant to reciprocity, and is currently licensed to practice pharmacy in the State of Ohio.  Records further reflect during the relevant time periods stated herein, Rayner B. Lotton was the Responsible Pharmacist at Berger Hospital pursuant to Sections 4729.27 and 4729.55 of the Ohio Revised Code and Section 4729-5-11 of the Ohio Admini­strative Code.

 

 

(2)

Rayner B. Lotton did, as the Responsible Pharmacist-in-charge, on or about August 26, 2001, (prior to dispensing a drug order to patient #1) upon review of the patient profile in order to conduct prospective drug utilization review, Rayner B. Lotton recognized over-utilization yet he failed to take appropriate steps to avoid or resolve the problem.  Rayner B. Lotton received a drug order for “Librium 300 mg one qid,” yet he dispensed the drug in spite of the over dosage and the patient suffered severe harm.  Such conduct is in violation of Rule 4729-5-20 of the Ohio Administrative Code.

 

 

(3)

Rayner B. Lotton did, as the Responsible Pharmacist-in-charge, on or about August 26, 2001, fail to implement policies and procedures consistent with federal and state laws and rules, and/or adhere to such policies and procedures, so as to provide for the safe and effective distribution of drugs, to wit: hospital and pharmacy policy provided that, when a pharmacist questioned the validity or propriety of a drug order, the pharmacist would contact the patient’s responsible nurse, who would then contact the physician.  Alternatively, a pharmacist must directly contact the prescrib­ing physician when questions or problems would arise to ensure the safe and effective distribution of drugs.  When dispensing a drug order on this date, due to adherence to this improper policy, a patient was harmed as indicated in paragraph 2 above.  Such conduct is in violation of Rule 4729-17-02(C)(3) of the Ohio Admini­strative Code.

 

 

Rayner B. Lotton neither admits nor denies the allegations stated in the Notice of Oppor­tunity for Hearing letter dated April 22, 2003; however, the Board has evidence sufficient to sustain the allegations and hereby adjudicates the same.

 

Wherefore, in consideration of the foregoing and mutual promises hereinafter set forth, and in lieu of a formal hearing at this time, Rayner B. Lotton knowingly and voluntarily agrees with the State Board of Pharmacy to the following:

 

 

(A)

Pursuant to Sections 4729.16 and 4729.25(B), Rayner B. Lotton is hereby repri­manded for the aforementioned violations of rules and/or laws.

 

 

(B)

In addition to any and all other Continuing Education requirements, Rayner B. Lotton agrees to attend 2.0 hours of continuing education within one year of the effective date of this agreement in the area of policies and procedures and other measures to prevent dispensing errors in hospital pharmacy practice.

 

 

Rayner B. Lotton acknowledges that he has had an opportunity to ask questions con­cerning the terms of this agreement and that all questions asked have been answered in a satisfac­tory manner.  Any action initiated by the Board based on alleged violation of this Agreement shall comply with the Administrative Procedure Act, Chapter 119. of the Ohio Revised Code.

 

Rayner B. Lotton waives any and all claims or causes of action he may have against the State of Ohio or the Board, and members, officers, employees, and/or agents of either, arising out of matters which are the subject of this Agreement.  Rayner B. Lotton waives any rights of appeal pursuant to Chapter 119. of the Ohio Revised Code.

 

 

In the event the Board, in its discretion, does not adopt this Agreement as its Adjudication, this settlement offer is withdrawn and shall be of no evidentiary value and shall not be relied upon or introduced in any disciplinary action or appeal by either party. Rayner B. Lotton agrees that should the Board reject this Agreement and if this case proceeds to hearing, he will assert no claim that the Board was prejudiced by its review and discussion of this Agreement or of any information relating thereto.

 

 

This Settlement Agreement shall be considered a public record, as that term is used in Sec­tion 149.43 of the Ohio Revised Code, and shall become effective upon the date of the Board President’s signature below.

 

/s/          Rayner B. Lotton

 

7–08–03

Rayner B. Lotton, R.Ph., Respondent

 

Date of Signature

/s/          David W. Grauer

 

7–8–03

David W. Grauer, Attorney for Respondent

 

Date of Signature

/s/          Robert P. Giacalone

 

7/14/03

Robert P. Giacalone, President, Ohio State Board of Pharmacy

 

Date of Signature

/s/          Sally Ann Steuk

 

7–14–03

Sally Ann Steuk, Ohio Assistant Attorney General

 

Date of Signature

 

R-2004-004

SETTLEMENT AGREEMENT WITH THE STATE BOARD OF PHARMACY

(Docket No. D-030701-001)

 

In The Matter Of:

 

DEBORAH S. MCCRAY, R.Ph.

3823 Behrwald Avenue

Cleveland, Ohio 44109

(R.Ph. No. 03-3-21891)

 

 

This Settlement Agreement is entered into by and between Deborah S. McCray 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.

 

Deborah S. McCray 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. Deborah S. McCray acknowledges that by enter­ing into this agreement she has waived her rights 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, Deborah S. McCray is licensed to practice pharmacy in the State of Ohio.

 

Whereas, Deborah S. McCray has no prior history of disciplinary proceedings of any kind.

 

Whereas, Deborah S. McCray, by and through her attorney, self-reported the conduct at issue herein to the Ohio State Board of Pharmacy and has been fully cooperative with the inves­tigation of this matter.

 

Deborah S. McCray neither admits nor denies the allegations stated in this Settlement Agreement, however, the Board has evidence sufficient to sustain the allegations and hereby adjudicates the same:

 

 

(1)

Records of the Board of Pharmacy indicate that Deborah S. McCray was originally licensed in the State Of Ohio on July 30, 1996, pursuant to examination, and is currently licensed to practice pharmacy in the State of Ohio.

 

 

(2)

Deborah S. McCray did, on or about April, 2002, with purpose to deprive, know­ingly obtain or exert control over dangerous drugs, the property of the Cleveland Department of Veterans Affairs Medical Center, beyond the express or implied consent of the owner, to wit: Deborah S. McCray has admitted to a Board of Phar­macy agent that she stole 25 unit doses of Ultram, a dangerous drug.  Though Deborah S. McCray had previously had valid prescriptions for the medication, such was not the case for the doses in April of 2002.  Such conduct constitutes dishonesty or unprofessional conduct in the practice of pharmacy within the meaning of Section 4729.16 of the Ohio Revised Code

 

 

Wherefore, in consideration of the foregoing and mutual promises hereinafter set forth, and in lieu of a formal hearing at this time, Deborah S. McCray knowingly and voluntarily agrees with the State Board of Pharmacy to the following:

 

(A)  Deborah S. McCray’s pharmacist identification card, No. 03-3-21891, will be placed on probation for two years from April 17, 2002, with the following conditions:

 

 

(1)  Pursuant to Deborah S. McCrays drug and alcohol assessment, she is not addicted.  However, Ms. McCray has voluntarily completed rehabilitation, and shall continue with her aftercare program.

 

(2)  The State Board of Pharmacy hereby declares that Deborah S. McCray’s phar­macist identification card is not in good standing.

 

(3)  Deborah S. McCray is not barred from practicing pharmacy during the period of her probation and/or while her pharmacist identification card is not in good standing.

 

(4)  Deborah S. McCray must not violate the drug laws of the State of Ohio, any other state, or the federal government.

 

(5)  Deborah S. McCray must abide by the rules of the State Board of Pharmacy.

 

(6)  Deborah S. McCray must comply with the terms of this Agreement.

 

 

If, in the judgment of the Board, Deborah S. McCray appears to have violated or breached any terms or conditions of this Agreement, the Ohio State Board of Pharmacy reserves the right to, at any time, revoke probation, modify the conditions of probation, and reduce or extend the period of probation, and/or the Board may institute formal disciplinary proceed­ings for any and all possible violations or breaches, including but not limited to, alleged violation of the laws of Ohio occurring before the effective date of this Agreement.

 

Deborah S. McCray 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.  Any action initiated by the Board based on alleged violation of this Agree­ment shall comply with the Administrative Procedure Act, Chapter 119. of the Ohio Revised Code.

 

Deborah S. McCray waives any and all claims or causes of action she may have against the State of Ohio or the Board, and members, officers, employees, and/or agents of either, arising out of matters which are the subject of this Agreement.  Deborah S. McCray waives any rights of appeal pursuant to Chapter 119. of the Ohio Revised Code.

 

In the event the Board, in its discretion, does not adopt this Agreement as its Adjudication, this settlement offer is withdrawn and shall be of no evidentiary value and shall not be relied upon or introduced in any disciplinary action or appeal by either party.  Deborah S. McCray agrees that should the Board reject this Agreement and if this case proceeds to hearing, she will assert no claim that the Board was prejudiced by its review and discussion of this Agreement or of any information relating thereto.

 

 

This Settlement Agreement shall be considered a public record, as that term is used in Sec­tion 149.43 of the Ohio Revised Code, and shall become effective upon the date of the Board President’s signature below.

 

/s/          Deborah S. McCray

 

9 Jul 2003

Deborah S. McCray, Respondent

 

Date of Signature

/s/          John A. Fatica

 

7/9/03

John A. Fatica, Attorney for Respondent

 

Date of Signature

/s/          Robert P. Giacalone

 

7/14/03

Robert P. Giacalone, President, Ohio State Board of Pharmacy

 

Date of Signature

/s/          Sally Ann Steuk

 

7–14–03

Sally Ann Steuk, Ohio Assistant Attorney General

 

Date of Signature

  8:25 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 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. Adelman and a roll call vote was conducted by President Giacalone as follows: Adelman-Yes, Braylock-Yes, Eastman-Yes, Gregg-Yes, Kost-Yes, Lipsyc-Yes, Teater-Yes, and Turner-Yes.

11:00 a.m.

 

The meeting was recessed for lunch.

12:57 p.m.

 

The Executive Session resumed with all members present.

  1:00 p.m.

 

The Executive Session ended and the meeting was opened to the public.

 

The Board members reviewed requests for reconsideration of Board Orders from William Ringle and Abdullah Abukhalil.  No action was taken on either request.

 

R-2004-005

Mr. Braylock moved that the Board reject the request for withdrawal of an application for a Terminal Distributor of Dangerous Drugs received from Ghassan Haj-Hamed, M.D. and that a hearing be scheduled.  The motion was seconded by Mr. Kost and approved by the Board (Aye-8/Nay-0).

 

R-2004-006

Mrs. Gregg then moved that the Board refuse the settlement offer issued in the matter of Alan Patrick Horvath, R.Ph. and that a hearing be scheduled.  The motion was seconded by Mr. Kost and approved by the Board (Aye-8/Nay-0).

 

R-2004-007

Mr. Braylock moved that the Board refuse the settlement offer issued in the matter of Tarra Bryant, R.Ph. and that a hearing be scheduled.  The motion was seconded by Ms. Eastman and approved by the Board (Aye-8/Nay-0).

 

R-2004-008

Mrs. Gregg then moved that the Board refuse the settlement offer issued in the matter of Maynard D. Turner, R.Ph. and that a hearing be scheduled.  The motion was seconded by Mr. Braylock and approved by the Board (Aye-8/Nay-0).

 

R-2004-009

Mr. Braylock moved that the Board refuse the settlement offer issued in the matter of David L. Rieder, R.Ph. and that a hearing be scheduled.  The motion was seconded by Mrs. Teater and approved by the Board (Aye-5/Nay-3).

 

R-2004-010

Mr. McMillen presented a request from Nick Femia, 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. Gregg moved that the request be approved until October 1, 2003 at the following two locations:

 

Mahoning Valley Hospital – Youngstown Campus (Application Pending)

    [Formerly Specialty Hospital of Mahoning Valley (02-1141750)]

Mahoning Valley Hospital – Trumbull Campus (Application Pending)

 

The motion was seconded by Mr. Kost and approved by the Board (Aye-8/Nay-0).

 

R-2004-011

Mr. Winsley presented a request from Timothy R. Tannert, R.Ph. asking for a waiver from the requirements of Rule 4729-5-11(A) to allow him to serve as responsible pharmacist at more than one location.  After discussion, Mr. Lipsyc moved that the request be approved until October 1, 2003 at the following two locations:

 

NCS Hilliard (02-0564600)

Omnicare of Columbus (02-1194500)

 

The motion was seconded by Mrs. Adelman and approved by the Board (Aye-8/Nay-0).

 

R-2004-012

Mr. Winsley then presented a request from Michael Pellek, R.Ph. asking for a waiver from the requirements of Rule 4729-5-11(A) to allow him to serve as responsible pharmacist for four Terminal Distributor licenses all located at one location.  After discussion, Mrs. Gregg moved that the request be approved for one year for the follow­ing licenses:

 

HCS At Home (02-1383800)

HCS Lancaster (02-1304400)

Conemaugh Home Medical Equipment (02-1349750)

Caring Services DME (02-1331700)

 

The motion was seconded by Mrs. Teater and approved by the Board (Aye-8/Nay-0).

 

R-2004-013

Mr. Winsley next presented a request from University Health Services (UHS) at the University of Cincinnati for an exemption to Rule 4729-5-10 (Pick-up station) so that patient-specific prescriptions could be prepared at the UHS Scioto Campus Pharmacy (02-1087400) and delivered to the UHS Holmes Clinic (Application Pending) for distribu­tion to patients who are students at the University.  After discussion, Mr. Braylock moved that the Board approve the request due to the need for involvement by a health care pro­fessional in the patient’s drug therapy [OAC Rule 4729-5-10(B)(5)(b)].  The motion was seconded by Ms. Eastman and approved by the Board (Aye-7/Nay-1).

 

R-2004-014

Mr. McMillen presented information received regarding a request for approval as a provider of continuing pharmacy education (CPE) from University Home Care/Pammi Farren, R.Ph.  The request for approval had been tabled at a previous meeting pending receipt of this information.  After discussion, Ms. Eastman moved that University Home Care be approved as a provider of CPE.  The motion was seconded by Mr. Kost and approved by the Board (Aye-8/Nay-0).

 

The Board next reviewed a brochure received from the Ohio Hospice & Palliative Care Organization regarding various rules and regulations pertinent to hospice care.  Before the Board would allow the Board’s name to be added to the brochure, Board staff was instructed to review the document carefully.  No action was taken on this issue until such a review could be accomplished.

 

R-2004-015

Mr. Winsley presented a request for reconsideration of the sanctions contained in his Board order from Bradley J. Heim, R.Ph.  After discussion, Mrs. Adelman moved that the Board deny the request for reconsideration.  The motion was seconded by Mr. Kost and approved by the Board (Aye-8/Nay-0).

 

R-2004-016

After discussion, Ms. Eastman moved that the Board continue their membership in the National Association of State Controlled Substance Authorities (NASCSA) and that the payment of dues for the following year be authorized.  The motion was seconded by Mr. Braylock and approved by the Board (Aye-8/Nay-0).

 

Mr. Braylock announced that the July meeting of the Nursing Board’s Committee on Prescriptive Governance had been cancelled.

 

Mr. Keeley then discussed his legislative report with the Board.

  2:29 p.m.

 

The Board took a brief recess.

  2:45 p.m.

R-2004-017

The meeting resumed.  Mr. Keeley discussed the rules proposed by the special com­mittee appointed to prepare rules regarding the Drug Repository program.  After dis­cus­sion of the proposed rules, Mrs. Gregg moved that the following rules be approved for fil­ing at the appropriate time:

 

 

PROPOSED NEW RULES

 

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.

 

 

The motion was seconded by Mr. Braylock and approved by the Board (Aye-8/Nay-0).

 

R-2004-018

Mr. Keeley next presented the rules proposed by the 2003 Ad Hoc Committee on Rule Review.  After discussion, Ms. Eastman moved that these rules be approved for filing at the appropriate time:

 

 

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.

 

 

The motion was seconded by Mrs. Gregg and approved by the Board (Aye-8/Nay-0).

 

A discussion was held regarding the continuing education rules.  Several proposals for additional methods to obtain CPE were discussed.  Staff was instructed to review the feasibility of granting CPE for attendance at Board meetings prior to the next meeting of the Board.

  4:40 p.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.  The motion was seconded by Mrs. Gregg and a roll call vote was conducted by President Giacalone as follows: Adelman-Yes, Braylock-Yes, Eastman-Yes, Gregg-Yes, Kost-Yes, Lipsyc-Yes, Teater-Yes, and Turner-Yes.

  5:00 p.m.

 

The meeting was recessed until Tuesday, July 15, 2003.

 

 

TUESDAY, JULY 15, 2003

 

  8:09 a.m.

ROLL CALL

 

 

The State Board of Pharmacy convened in the Starboard Room at Maumee Bay Confer­ence Center, 1750 Park Road #2, Oregon, Ohio with the following members present:

 

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

 

Mr. Lipsyc was unable to attend due to illness.

  8:15 a.m.

 

After discussing the draft of the minutes from the June 2003 meeting, Mrs. Adelman moved that the minutes be approved as amended.  The motion was seconded by Mrs. Gregg and approved by the Board (Aye-7/Nay-0).

 

R-2004-019

Mr. McMillen presented a request for approval as a provider of CPE received from Absolute Pharmacy.  After discussion, Mrs. Gregg moved that the Board approve Absolute Pharmacy as a provider of CPE.  The motion was seconded by Mr. Braylock and approved by the Board (Aye-7/Nay-0).

 

R-2004-020

Mr. Winsley presented a request from Christopher Kiel, R.Ph. asking for a waiver from the requirements of Rule 4729-5-11(A) to allow him to serve as responsible pharmacist at more than one location.  After discussion, Mr. Braylock moved that the request be approved for one year at the following two locations:

 

Teregen Labs (02-1235150)

Drug World Compounding Pharmacy (02-1179100)

 

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

 

 

The Board members and Board staff then discussed topics of general interest that re­quired no official action by the Board at this time.  Discussion topics included technician issues, appropriate questions during a Board hearing, site visits for Board member edu­cation, and the use of outdated drugs for training.

11:45 a.m.

 

After the above discussion finished, Mrs. Gregg moved that the Board receive Per Diem as follows:

 

PER DIEM

6/12

7/14

7/15

Total

Adelman

-

1

1

2

Braylock

-

1

1

2

Eastman

-

1

1

2

Giacalone

1

1

1

3

Gregg

-

1

1

2

Lipsyc

1

1

-

2

Kost

-

1

1

2

Teater

-

1

1

2

Turner

-

1

1

2

 

 

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

11:47 a.m.

 

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

 

 

THE BOARD APPROVED THESE MINUTES

AUGUST 4, 2003