NOTE:  The following Minutes are provided for informational purposes only.

If you would like to obtain an official copy of these Minutes, please contact the

State Board of Pharmacy at 614/466-4143 for instructions and fee.

 

 

 

Minutes Of The Meeting

Ohio State Board of Pharmacy

Columbus, Ohio

March 6, 7, 2000

 

MONDAY, MARCH 6, 2000

 

12:08 p.m.      ROLL CALL

 

The State Board of Pharmacy convened in Room 1914, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio with the following members present:

 

Robert B. Cavendish, R.Ph. (President); Diane C. Adelman, R.Ph. (Vice-President); Ann D. Abele, R.Ph.; Suzanne R. Eastman, R.Ph.; Robert P. Giacalone, R.Ph.; Lawrence J. Kost, R.Ph.; and Nicholas R. Repke, Public Member.

 

Also present were William T. Winsley, Executive Director; Timothy Benedict, Assistant Executive Director; David Rowland, Legal Affairs Administrator; and Sally Ann Steuk, Assistant Attorney General.

 

Mr. Winsley announced that, due to a change in the hearing schedule, the Board meeting would be only two days instead of three as originally scheduled.  There would be no need to continue the meeting into Wednesday.

12:10 p.m.

Ms. Abele moved that the Board go into Executive Session for the purpose of the investigation of complaints regarding licensees and registrants pursuant to Section 121.22(G)(1) of the Revised Code and for the purpose of conferring with an attorney for the Board regarding pending or imminent court action pursuant to Section 121.22(G)(3) of the Revised Code.  The motion was seconded by Ms. Eastman and a roll call vote was conducted by President Cavendish as follows: Abele-Yes, Adelman-Yes, Eastman-Yes, Giacalone-Yes, Kost-Yes, and Repke-Yes.

  1:28 p.m.

Mr. Littlejohn arrived and joined the Executive Session.

  2:28 p.m.

The Executive Session ended and the Board meeting resumed in Public Session.

 

RES. 2000-124   Ms. Abele then moved that, pursuant to Section 3719.121 of the Revised Code, the Board summarily suspend the license to practice pharmacy belonging to Michael Scott Gladeiux, R.Ph. (03-1-19036) due to the fact that a continuation of his professional practice presents a danger of immediate and serious harm to others.  The motion was seconded by Mr. Repke and approved by the Board (Aye-6/Nay-0/Abstain-1[Littlejohn]).

  2:35 p.m.

The Board took a brief recess.

  2:55 p.m.

Mr. Winsley and Mr. Benedict reviewed current and pending legislation with the Board.  There were no matters requiring official action of the Board regarding legislation.

  3:15 p.m.

RES. 2000-125   After a discussion of the concerns that were raised about Proposed New Rule 4729-5-14, particularly from hospice organizations, Ms. Abele moved that the Board appoint Phyllis Grauer, R.Ph., and Jerry Marlowe, R.Ph. as two additional members familiar with hospice-related issues to the Ad Hoc Committee on Rule Review to assist in the revision and re-filing of the rule.  The motion was seconded by Ms. Eastman and approved by the Board (Aye-7/Nay-0).

  3:20 p.m.

RES. 2000-126   Ms. Abele then moved that the Board approve the following rules for final filing and instruct Board staff to file the rules with the appropriate agencies with an effective date of March 31, 2000.  The motion was seconded by Ms. Eastman and approved by the Board (Aye-7/Nay-0).

 

4729-5-10   Prescription pick-up station.

 

(A)  No pharmacist shall accept prescriptions obtained from a place which offers, in any manner, its services as a "pick-up station" or intermediary for the purpose of having prescriptions filled UNLESS SUCH PLACE IS A PHARMACY AS DEFINED IN SECTION 4729.01 OF THE REVISED CODE, HAS RECEIVED BOARD APPROVAL TO FUNCTION IN SUCH A MANNER., AND ALL OF THE FOLLOWING APPLY:

 

(1)  THE SITE IS LICENSED WITH THE STATE BOARD OF PHARMACY AS A TERMINAL DISTRIBUTOR OF DANGEROUS DRUGS;

 

(2)  THE RECEIPT, STORAGE, CONTROL, AND DISTRIBUTION OF PRESCRIPTIONS ARE IN THE FULL AND ACTUAL CHARGE OF A PHARMACIST LICENSED PURSUANT TO CHAPTER 4729. OF THE REVISED CODE;

 

(3)  AN APPROPRIATE RECORDKEEPING SYSTEM IS IN PLACE THAT WILL PROVIDE ACCOUNTABILITY FOR PROPER RECEIPT, DELIVERY, AND RETURN OF ALL PRESCRIPTIONS;

 

(4)  THERE IS A DOCUMENTED METHOD IN PLACE TO ENSURE COMPLIANCE WITH RULE 4729-5-22 OF THE ADMINISTRATIVE CODE.

 

(B)  No pharmacist shall dispense dangerous drugs to a place which offers, in any manner, its services as a "pick-up station" or intermediary for the purpose of having prescriptions filled or delivered unless SUCH PLACE IS A PHARMACY AS DEFINED IN SECTION 4729.01 OF THE REVISED CODE, HAS RECEIVED BOARD APPROVAL TO FUNCTION IN SUCH A MANNER, AND PARAGRAPHS (B)(1) THROUGH (B)(4) OF THIS RULE APPLY OR, IF NOT A PHARMACY, UNLESS all of the following apply:

 

(1)  The site is licensed with the state board of pharmacy as a terminal distributor of dangerous drugs.

 

(2)  The receipt, storage, control, and distribution of prescriptions or drugs are in the full and actual charge of a health care professional licensed pursuant to Chapter 4723., 4729., or 4731. of the Revised Code.

 

(3)  An appropriate recordkeeping system is in place that will provide accountability for proper receipt, and delivery, AND RETURN of all prescription medications.

 

(4)  There is a documented method in place to ensure compliance with rule 4729-5-22 of the Administrative Code.

 

(5)  The state board of pharmacy has approved the site for such activity due to clear and convincing evidence that delivery of prescription medication directly to the patient would result in:

 

(a)  Danger to public health or safety, or

 

(b)  Danger to the patient without increased involvement by a health care professional in the patient’s drug therapy.

 

4729-5-13   Prescription format.

 

EXCEPT AS PROVIDED IN RULE 4729-5-14 OF THE ADMINISTRATIVE CODE:

 

(A)  No pharmacist shall dispense dangerous drugs pursuant to a written outpatient prescription unless the following conditions are met:

 

(1)  The prescription is issued in compliance with rule 4729-5-30 of the Administrative Code.

 

(2)  If preprinted with multiple drug name and strength combinations:

 

(a)  There are no controlled substances among the choices;

 

(b)  There is only one prescription order selected per form.

 

(B)  No prescriber shall write and no pharmacist shall dispense controlled substances pursuant to a written outpatient prescription unless the following conditions are met:

 

(1)  The prescription has been issued in compliance with rule 4729-5-30 of the Administrative Code.

 

(2)  The prescription contains only one prescription order per prescription form, whether handwritten or preprinted.

 

(3)  The quantity has been written both numerically and alphabetically.

 

(4)  If preprinted, there is only one drug and strength combination printed on the form.

 

(C)  A prescription issued by a medical intern, resident, or fellow as defined in paragraph (B) of rule 4729-5-15 of the Administrative Code may not be dispensed unless the prescription is issued in compliance with this rule and rule 4729-17-13 of the Administrative Code and unless it bears the identification number issued by the employing hospital or institution pursuant to rule 4729-17-13 of the Administrative Code.

 

(D)  A prescription issued by a staff prescriber of a hospital may not be dispensed unless the prescription is issued in compliance with this rule and rule 4729-17-13 of the Administrative Code and unless it bears the identification number issued by the employing hospital or institution pursuant to rule 4729-17-13 of the Administrative Code.

 

4729-5-16   Labeling of drugs dispensed on prescription.

 

(A)  No drug may be dispensed on prescription unless a label is affixed to the container in which such drug is dispensed and such label includes:

 

(1)  The name and address of the pharmacy as it appears on the terminal distributor of dangerous drugs license UNLESS IT IS FILLED PURSUANT TO A BOARD-APPROVED CENTRAL FILLING OPERATION, IN WHICH CASE THE LABEL SHALL BEAR THE NAME AND ADDRESS OF THE ORIGINATING PHARMACY AS IT APPEARS ON THE TERMINAL DISTRIBUTOR OF DANGEROUS DRUGS LICENSE;

 

(2)  The name of the patient for whom the drug is prescribed; or, if the patient is an animal, the name of the owner and the species IDENTIFICATION of the animal;

 

(3)  The name of the prescriber;

 

(4)  Directions for use of the drug;

 

(5)  The date of dispensing;

 

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

 

(7)  The serial number of the prescription;

 

(8)  The proprietary name, if any, or the generic name and the name of the distributor of the drug dispensed; and the strength, if more than one strength of the drug is marketed.  The dispensing pharmacist may omit the name and strength of the drug only if the prescriber specifically requests omission in writing in the case of a written prescription, or verbally in the case of an orally transmitted prescription;

 

(9)  The quantity of drug dispensed;

 

(10)  IF FILLED AS PART OF A BOARD-APPROVED CENTRAL FILLING OPERATION, AN IDENTIFICATION OF THE PHARMACY PROVIDING THE DRUGS FOR THE DISPENSING OPERATION.

 

(B)  The term "affix" means the prescription label must be attached or fastened to the container.

 

(C)  At least the prescription number and the name of the patient must be placed on all prescription containers too small to bear a complete prescription label and dispensed in a container bearing a complete prescription label.  The label bearing only the prescription number and the name of the patient does not need to be applied to any product whose function would be impaired by such a label.  In all cases, a complete prescription label meeting the requirements of paragraph (A) of this rule must be applied to the container in which such product is dispensed.

 

(D)  This rule does not apply to drugs which are dispensed for use by inpatients of an institutional facility whereby the drug is not in the possession of the ultimate user prior to administration.  Such drugs shall be labeled in accordance with rule 4729-17-10 of the Administrative Code.

 

4729-5-17   Labeling by prescribers who personally furnish dangerous drugs to their patients.

 

(A)  Whenever a prescriber personally furnishes a dangerous drug, other than a sample drug pursuant to section 3719.81 of the Revised Code, the prescriber shall affix to the container a label showing:

 

(1)  The name and address of the prescriber.

 

(2)  The name of the patient for whom the drug is intended.  If the patient is an animal, the name of the owner and the species IDENTIFICATION of the animal.

 

(3)  Name and strength of the dangerous drug.

 

(4)  Directions for use.

 

(5)  Date furnished.

 

(B)  Whenever a prescriber personally furnishes a dangerous drug, labeled as a sample pursuant to section 3719.81 of the Revised Code and where the directions for use are different from the directions on or in the sample container, the prescriber shall also provide, in written format, the following:

 

(1)  Name of the prescriber.

 

(2)  Name of the patient.  If the patient is an animal, the name of the owner and the species IDENTIFICATION of the animal.

 

(3)  Directions for use.

 

4729-5-19   Serial numbering of prescriptions.

 

All outpatient prescriptions must be serially numbered when entered into the computer system or when dispensed under a manual system.

 

(A)  This number must appear on the original prescription.  If an alternate recordkeeping system is being used pursuant to rules 4729-5-27 and 4729-5-28 of the Administrative Code, the serial number must also appear on the records in this alternate system.

 

(B)  There must be a complete accounting of all numbers used in the serial numbering system.

 

(C)  All prescriptions which are not refillable, either because of the dispensing of all refills or the length of time since issuance, shall be assigned a new serial number upon authorization by the prescriber to continue the medication, except:

 

(1)  The prescriber may authorize additional refills of a schedule III or IV controlled substance through an oral refill authorization transmitted to a pharmacist, provided the additional refills do not exceed five refills of the original prescription nor does any refill occur beyond six months from the date of issuance of the original prescription; or

 

(2)  The prescriber may authorize additional refills of a schedule V controlled substance or a non-controlled drug through an oral refill authorization transmitted to a pharmacist provided that no refill may occur beyond one year from the date of issuance of the original prescription.

 

(3)  All additional refills authorized by the prescriber shall be marked on the original prescription listing authorizing agent, date, number of refills authorized, and pharmacist receiving the authorization.  If an alternative recordkeeping system is used, this information must also be maintained in that system.

 

(D)  IN THE CASE OF A BOARD-APPROVED CENTRAL FILLING OPERATION IN WHICH THE PHARMACIES ARE ACCESSING THE SAME REAL-TIME, ON-LINE DATABASE, THE SERIAL NUMBER USED MAY BE THE ORIGINAL SERIAL NUMBER ISSUED AT THE ORIGINATING PHARMACY IF ALL OF THE FOLLOWING REQUIREMENTS ARE MET:

 

(1)  THE COMPUTER SYSTEM MAINTAINS THE APPROPRIATE RECORDS FOR THE PRESCRIPTION SO THAT IT IS POSSIBLE TO DETERMINE THE IDENTITY OF EVERY PERSON INVOLVED IN THE DISPENSING OF THE PRESCRIPTION WHO PERFORMS AN ACT THAT WOULD CONSTITUTE THE PRACTICE OF PHARMACY.

 

(2)  THE COMPUTER SYSTEM ASSIGNS A UNIQUE INTERNAL CODE TO THE PRESCRIPTION SO THAT IT IS POSSIBLE TO DETERMINE THE LOCATION OF THE PERSONNEL INVOLVED IN THE DISPENSING AS WELL AS THE LOCATION OF THE DRUG STOCK USED IN THE DISPENSING FUNCTION.

 

4729-5-24   Prescription copy.

 

(A)  A pharmacist may transfer a copy of a prescription; a pharmacist may refill a copy of a prescription; such actions must be in accordance with the following:

 

(1)  Copies of prescriptions shall be transferred only between pharmacists; copies of prescriptions for controlled substances pursuant to sections 3719.41, 3719.43, and 3719.44 of the Revised Code shall be communicated directly between two pharmacists and shall be transferred only one time.  However, pharmacies electronically sharing a real-time, on-line database may transfer a controlled substance prescription up to the maximum number of refills permitted by law and the prescriber's authorization pursuant to paragraph (A)(4) of this rule.

 

(2)  The copy transferred shall be an exact duplicate of the original prescription except that it shall also include:

 

(a)  Serial prescription number assigned to the prescription;

(b)  Name and address (and "D.E.A." number for controlled substance prescriptions) of the pharmacy transferring the copy;

(c)  Date of issuance of the prescription;

(d)  Date of original dispensing of the prescription;

(e)  Original number of refills;

(f)  Date of last refill;

(g)  Number of valid refills remaining; and

(h)  The name of the transferring pharmacist.

 

(3)  Copies transferred for non-refillable prescriptions shall be marked on the face of the prescription or orally noted by the transferring pharmacist "For Information Purposes Only" and are not valid prescriptions for the dispensing of drugs.

 

(4)  The pharmacist transferring a copy of a prescription must:

 

(a)  Cancel the original prescription by writing the word "void" on the face of the prescription in such a way as to avoid destroying any of the original information contained on the prescription;

 

(b)  Record on the reverse side of the original written prescription:

 

(i)  Date of transfer;

 

(ii)  His/her signature; and

 

(iii)  When transferring an oral prescription, the name and address (and "D.E.A." number for controlled substance prescriptions) OF, and name of the pharmacist at, the receiving pharmacy.

 

(c)  Except, if an automated data processing system is being used as an alternate system of recordkeeping for prescriptions pursuant to rules 4729-5-27 and 4729-5-28 of the Administrative Code, copies of prescriptions may be transferred by a pharmacist if the prescription record in the system is invalidated to prevent further dispensing at the original site.  The prescription record in the system must contain the date of transfer, name of pharmacist making transfer, and the name and address of the pharmacy receiving the copy.  Also, original written prescriptions for controlled substances must be canceled as required in paragraphs (A)(4)(a) and (A)(4)(b) of this rule.

 

(5)  The pharmacist receiving a copy of a prescription must:

 

(a)  Exercise reasonable diligence to determine validity of the copy;

 

(b)  Reduce an oral prescription to writing by recording all of the information transferred (must include all information required in paragraph (A)(2) of this rule) and write the word "transfer" on the face of the prescription;

 

(c)  Record date of transfer on the face of the prescription.

 

(B)  A prescription copy may be transferred between two pharmacies if the two pharmacies are accessing the same prescription records in a centralized database or pharmacy computers linked in any other manner.  The computerized systems must satisfy all information requirements of paragraphs (A)(2) and (A)(4)(c) of this rule.  This shall include invalidation of the prescription record in the system to prevent further dispensing at the original site and, if a controlled substance prescription, the canceling of the original written prescription as required in paragraphs (A)(4)(a) and (A)(4)(b) of this rule.  A system must be in place that will allow only authorized access to these computerized prescription records by a pharmacist and indicate on the prescription record when and by whom such access was made.

 

(C)  A prescription copy may be transferred between two pharmacists by the use of a facsimile machine.  This facsimile may be considered to be a copy of a prescription if all information requirements of paragraph (A) of this rule, including invalidation of the original prescription or computer records, are met.  A system must be in place that will show on the facsimile positive identification of the transferring and receiving pharmacists which must become a part of the prescription record.  Facsimile copies must be recorded in writing pursuant to section 4729.37 of the Revised Code, or stored in such a manner that will allow retention of the prescription record for three years from the date of the last transaction.

 

(D)  Information on a prescription is the property of the patient and is intended to authorize the dispensing of a specific amount of medication for use by the patient.  Original copies of prescriptions shall be maintained by pharmacies for the purpose of documenting the dispensing of drugs to a particular patient.

 

(1)  In the event that the pharmacy is not able to provide the medication when needed by the patient pursuant to an authorized refill, the pharmacist shall, upon the request of the patient, transfer the prescription information to the pharmacy designated by the patient.

 

(2)  No pharmacy shall refuse to transfer information about a previously dispensed prescription to another pharmacy when requested by the patient.  Prescription information shall be transferred in accordance with this rule as soon as possible in order to assure that the patient’s drug therapy is not interrupted.

 

(E)  Prescriptions entered into a computer system but not dispensed may be transferred to another pharmacy if all of the following conditions are met:

 

(1)  The complete prescription information has been entered into the computer system;

 

(2)  the information is displayed on the patient’s profile;

 

(3)  There is positive identification, either in the computer system or on the hard-copy prescription, of the pharmacist who is responsible for entering the prescription information into the system;

 

(4)  The original prescription is filed in accordance with rule 4729-5-09 of the Administrative Code;

 

(5)  All requirements of this rule are met for the transfer of the prescription.

 

(F)  TRANSFER OF PRESCRIPTION INFORMATION BETWEEN TWO PHARMACIES WHICH ARE ACCESSING THE SAME REAL-TIME, ON-LINE DATABASE PURSUANT TO THE OPERATION OF A BOARD-APPROVED CENTRAL FILLING OPERATION SHALL NOT BE CONSIDERED A PRESCRIPTION COPY AND, THEREFORE, IS NOT SUBJECT TO THE REQUIREMENTS OF THIS RULE.

 

4729-5-30   Manner of issuance of prescription.

 

(A)  A prescription, to be effective, must be issued for a legitimate medical purpose by an individual prescriber acting in the usual course of his/her professional practice.  The responsibility for the proper prescribing is upon the prescriber, but a corresponding responsibility rests with the pharmacist who dispenses the prescription.  An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription and the person knowingly dispensing such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law.

 

(B)  All prescriptions shall be dated as of and signed on the day when issued, and shall bear the full name and address of the patient.

 

(C)  All written prescriptions issued by a prescriber shall bear the full name and address of the prescriber and shall be manually signed by the prescriber in the same manner as he/she would sign a check or legal document.

 

(D)  An original signed prescription (for other than a schedule II controlled substance except as noted in paragraph (N) of this rule and rules 4729-17-09 and 4729-19-02 of the Administrative Code) may be transmitted as an "other means of communication" to a pharmacist PHARMACY by the use of a facsimile machine only by a prescriber or the prescriber's agent.  Such a facsimile shall only be valid as a prescription if a system is in place that will allow the pharmacist to maintain the facsimile as a part of the prescription record including the positive identification of the prescriber and his/her agent as well as positive identification of the origin of the facsimile.  The pharmacist must record the prescription in writing pursuant to section 4729.37 of the Revised Code or store the facsimile copy in such a manner that will allow retention of the prescription record for three years from the date of the last transaction.  The original signed prescription from which the facsimile is produced shall not be issued to the patient.  The original signed prescription must remain with the patient’s records at the prescriber’s office or the institutional facility where it was issued.  IF A BOARD-APPROVED ELECTRONIC PRESCRIPTION TRANSMISSION SYSTEM IS USED TO FAX THE PRESCRIPTION, THE COMPUTER DATA MUST BE RETAINED FOR A PERIOD OF THREE YEARS AT THE PRESCRIBER'S OFFICE.  A facsimile of a prescription received by a pharmacist PHARMACY in any manner other than transmission directly from the prescriber or the prescriber’s agent shall not be considered a valid prescription, except as a copy of a prescription pursuant to rule 4729-5-24 of the Administrative Code.

 

(E)  All prescriptions shall specify the number of times or the period of time for which the prescription may be refilled.  A prescription marked "Refill P.R.N." or some similar designation is not considered a valid refill authorization.

 

(F)  Prescriptions for dangerous drugs may not be dispensed for the first time beyond six months from the date of issuance by a prescriber.

 

(G)  Prescriptions for dangerous drugs and controlled substances in schedule V may not be authorized for refill beyond one year from the date of issuance.  Prescriptions for controlled substances in schedules III and IV shall be authorized for refill only as permitted by section 3719.05 of the Revised Code.  Prescriptions for controlled substances in schedule II may not be refilled.

 

(H)  A prescription may be refilled only as expressly authorized by the prescriber, either in writing or orally.  If no such authorization is given, the prescription may not be refilled except in accordance with section 4729.281 of the Revised Code.

 

(I)  The drug(s) in a compounded prescription or drug product shall be identified by the product trade name or generic name.

 

(J)  No prescription shall be coded in such a manner that it cannot be dispensed by any pharmacy of the patient's choice.  A "coded prescription" is one which bears letters, numbers, words or symbols, or any other device used in lieu of the name, quantity, strength and directions for its use, other than those normal letters, numbers, words, symbols, or other media recognized by the profession of pharmacy as a means of conveying information by prescription.  No symbol, word, or any other device shall be used in lieu of the name of said preparation.

 

(K)  The agent of a prescriber who transfers a facsimile of an original prescription or transmits an oral prescription or authorization of a refill for a dangerous drug must identify themselves by full name and the pharmacist shall make a record of the prescriber's agent on the original prescription and, if used, on the alternate system of recordkeeping.  A pharmacist who modifies a patient's drug therapy, pursuant to a consult agreement, must personally transmit the facsimile or oral order to another pharmacist, if the drug is not dispensed by the pharmacist who modified the drug order.

 

(L)  When forms are used that create multiple copies of a prescription issued to a patient by a prescriber, the original prescription which also bears the actual signature of the prescriber must be issued to the patient for dispensing by a pharmacist.

 

(M)  A pharmacist may accept, without further verification of the prescriber’s identity required, a prescription that has been transmitted by means of a board approved BOARD-APPROVED automated paperless system.  The system shall require positive identification of the prescriber as defined in rule 4729-5-01 of the Administrative Code as well as the full name of any authorized agent of the prescriber who transmits the prescription.

 

(N)  A schedule II controlled substance prescription for a narcotic substance issued for a patient enrolled in a hospice may be transmitted by the prescriber or the prescriber's agent to the pharmacy by facsimile.  The original prescription must indicate that the patient is a hospice patient.  The facsimile transmission must meet all of the requirements in paragraph (D) of this rule for such a prescription.

 

(O)  When a pharmacist, acting as an agent of the physician, modifies a patient’s drug therapy pursuant to a consult agreement, the pharmacist must comply with this rule in the same manner as a prescriber and include the name of the physician who originally prescribed the drug and sign the pharmacist's full name.

 

(P)  A PRESCRIPTION ORALLY TRANSMITTED BY TELEPHONE TO A PHARMACY BY A PRESCRIBER OR THE PRESCRIBER'S AGENT MAY BE PLACED ON A RECORDING DEVICE AT THE PHARMACY IF THE PHARMACIST IS UNAVAILABLE.  THE PRESCRIBER OR PRESCRIBER'S AGENT MUST PROVIDE HIS/HER COMPLETE NAME.  THE PHARMACIST MUST REMOVE THE PRESCRIPTION FROM THE RECORDER AND REDUCE IT TO WRITING.  THE PHARMACIST IS RESPONSIBLE FOR ASSURING THE VALIDITY OF THE PRESCRIPTION REMOVED FROM THE RECORDER.

 

4729-5-33   Criteria for re-licensure by reciprocity.

 

A person who has been registered as a pharmacist pursuant to section 4729.07 or 4729.09 of the Revised Code, and whose identification card has lapsed, may obtain an identification card to practice pharmacy in Ohio pursuant to section 4729.09 of the Revised Code provided he/she:

 

(A)  Submits evidence of having obtained four and one-half "C.E.U.s" of approved continuing pharmacy education pursuant to Chapter 4729-7 MET THE REQUIREMENTS OF RULE 4729-7-02 of the Administrative Code during the three-year period immediately preceding the date of application; or

 

(B)  Is reciprocating from a state where continuing pharmacy education is mandatory and submits evidence of having met the continuing pharmacy education requirements of that state.

 

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 species 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 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, 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 species 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, 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.

 

4729-11-01  Controlled substance schedule I.

4729-11-02  Controlled substance schedule II.

4729-11-03  Controlled substance schedule III.

4729-11-04  Controlled substance schedule IV.

 

Rescinded to remove duplication of the Revised Code.

The rescission of these rules will NOT affect the "Ohio's Schedules of Controlled Substances" list as it is currently in effect.

 

4729-11-09  Sale of schedule V controlled substance products without a prescription.

 

A schedule V controlled substance product which is not a prescription drug as determined under the “Federal Food, Drug and Cosmetic Act” may be sold at retail by a pharmacist without a prescription to a purchaser at retail, provided that:

 

(A)  the sale is made only by a pharmacist OR A PHARMACY INTERN UNDER THE DIRECT SUPERVISION OF A PHARMACIST and not by a nonpharmacist employee even if under the supervision of a pharmacist (although after the pharmacist has fulfilled his professional and legal responsibilities in this section, the actual cash, credit transaction, or delivery may be completed by a nonpharmacist).

 

(B)  the purchaser is at least eighteen years of age.

 

(C)  the pharmacist requires every purchaser of a controlled substance under this rule not known to him to furnish suitable identification (including proof of age where appropriate).

 

(D)  a bound record book is maintained which contains the true name and complete address of the purchaser, the legible signature of the purchaser, the name and quantity of controlled substances sold, the date of each sale, and the name and legible initials of the pharmacist who sold the controlled substance at retail.  This book shall be maintained for a period of three years from the date of the last transaction and must be made available for inspection and copying by persons authorized to enforce the federal and state drug laws.

 

(E)  the schedule V controlled substance product is sold at retail.

 

(F)  not more than two hundred forty milliliters (eight ounces) nor more than forty-eight solid dosage units of any schedule V controlled substance product containing opium, nor more than one hundred twenty milliliters (four ounces) nor more than twenty-four solid dosage units of any other narcotic controlled substance may be sold at retail to the same purchaser in any consecutive forty-eight-hour period.

 

(G)  not more than one hundred solid dosage units of any schedule V controlled substance stimulant product may be sold to any one person in any consecutive thirty-day period.

 

(H)  the schedule V controlled substance is sold at retail for a legitimate medical need and the purchaser furnishes information to the pharmacist which establishes the legitimate medical need for the controlled substance.

 

4729-12-02  Registration and licensure.

 

(a)  Any person who manufactures, sells at wholesale or retail, dispenses, imports or exports products containing ephedrine, its salts or isomers, or who proposes to engage in such activities, shall submit an application for registration as a wholesaler of dangerous drugs and controlled substances or for licensure as a category III terminal distributor of dangerous drugs to conduct such activities in accordance with Chapters 3719. and 4729. of the Revised Code.

 

(B)  THIS SECTION DOES NOT APPLY IF THE EPHEDRINE PRODUCT IS A FOOD PRODUCT OR A DIETARY SUPPLEMENT THAT IS SPECIFICALLY EXCEPTED IN DIVISION (K)(2) OF SECTION 3719.44 OF THE REVISED CODE.

 

4729-12-03  Security, storage, and sale.

 

(a)  Schedule V products containing ephedrine may be sold at wholesale or retail, and must be maintained in accordance with Chapters 3719. and 4729. of the Revised Code and Chapters 4729-9 and 4729-11 of the Administrative Code.

 

(B)  THIS SECTION DOES NOT APPLY IF THE EPHEDRINE PRODUCT IS A FOOD PRODUCT OR A DIETARY SUPPLEMENT THAT IS SPECIFICALLY EXCEPTED IN DIVISION (K)(2) OF SECTION 3719.44 OF THE REVISED CODE.

 

4729-12-04  Inventory.

 

(a)  Every registrant or licensee required to keep records who possesses any quantity of ephedrine or schedule V drug products containing ephedrine shall take an inventory pursuant to rules 4729-9-14 and 4729-9-16 of the Administrative Code.

 

(B)  THIS SECTION DOES NOT APPLY IF THE EPHEDRINE PRODUCT IS A FOOD PRODUCT OR A DIETARY SUPPLEMENT THAT IS SPECIFICALLY EXCEPTED IN DIVISION (K)(2) OF SECTION 3719.44 OF THE REVISED CODE.

 

4729-12-05  Records.

 

(a)  All practitioners, registrants, and licensees required to keep records pursuant to Chapter 3719. of the Revised Code and Chapters 4729-9 and 4729-11 of the Administrative Code shall maintain such records for ephedrine and schedule V drug products containing ephedrine.

 

(B)  THIS SECTION DOES NOT APPLY IF THE EPHEDRINE PRODUCT IS A FOOD PRODUCT OR A DIETARY SUPPLEMENT THAT IS SPECIFICALLY EXCEPTED IN DIVISION (K)(2) OF SECTION 3719.44 OF THE REVISED CODE.

 

4729-12-08  Petitions for exception of ephedrine-containing products.

 

(a)  A petition requesting that a drug product containing ephedrine be excepted by the board of pharmacy from being legally classified as a schedule V controlled substance stimulant may be submitted by any person engaged in the legitimate manufacture or wholesale sale of such products in the United States.  The petition shall include the following information:

 

(A)  (1)  full name, address, and telephone number of the manufacturer.

 

(1)  (a)  If incorporated, the petition must include copies of the incorporation papers and the names, dates of birth, addresses, and social security numbers of the officers of the corporation and all stockholders holding more than ten percent of the stock.

 

(2)  (b)  If a proprietorship, the petition must include the name, address, date of birth, and social security number of the owner(s).

 

(3)  (c)  If a partnership, the petition must include the names, addresses, dates of birth, and social security numbers of the partners.

 

(B)  (2)  a description of the package sizes and the manner of packaging the drug product.

 

(C)  (3)  A limited number of samples of each dosage form marketed in the final marketed packages.

 

(D)  (4)  the manner of distribution, advertising, and promotion of the product, including but not limited to:

 

(1)  (a)  the full name and address of all accounts located in Ohio to which the products have been or will be distributed at wholesale based on other products marketed by the petitioner.

 

(2)  (b)  Copies of all advertisements used to promote the product within the last twelve months shall be included with the petition.  A list of the publications in which the advertisements appeared or will appear if not presently marketed.  if the product has not yet been marketed, copies of other products marketed by the petitioner shall be submitted with the petition.

 

(E)  (5)  a listing of all ingredients in the product, indicating the quantity of each ingredient, whether or not it has any therapeutic value, and its purpose for being included in the product.  Documentation of the therapeutic value of all active ingredients in the product shall be included with the petition.

 

(F)  (6)  A list of all names the product is marketed or will be marketed under in the United States or any other country.

 

(G)  (7)  any information regarding the product’s abuse or potential for abuse in the United States or other countries where the product is marketed or will be marketed under any of the names listed in paragraph (F) (A)(6) of this rule.

 

(B)  THIS SECTION DOES NOT APPLY IF THE EPHEDRINE PRODUCT IS A FOOD PRODUCT OR A DIETARY SUPPLEMENT THAT IS SPECIFICALLY EXCEPTED IN DIVISION (K)(2) OF SECTION 3719.44 OF THE REVISED CODE.

 

4729-22-04  Prescriber's order.

 

Before making an initial sale of medical oxygen to a patient, the retail seller must have an order issued by a person authorized to prescribe oxygen in the course of the prescriber’s professional practice.  the order must include the full name and address of the patient, the name and address of the prescriber, and documentation of need.  THIS ORDER MUST BE RENEWED AT LEAST ANNUALLY.

  3:30 p.m.

RES. 2000-127   The Board was joined by William McMillen, Licensing Administrator, for a report and discussion on licensing issues.  In addition, Mr. McMillen reviewed Resolution 83-095 with the Board, particularly regarding the actions to be taken when a limited partnership is formed by two existing organizations.  Ms. Abele moved that a limited partnership should be added to the list and that the resolution be changed as follows:

 

PROCEDURE FOR CHANGES IN DRUG DISTRIBUTOR LICENSURE

 

 

Conditions

New

 Lic 1

New

ID#

New

Fee

Dis

Bus

New

App

New

Add

 

 

 

 

 

 

 

CHANGE OF OWNERSHIP

 

 

 

 

 

 

Limited Liability CompanyA

R

R

R

R

R

 

Sole Proprietorship

R

R

R

R

R

 

Corporate

 

 

 

 

 

 

existing corp. ceases-new corp.

R

R

R

R

R

 

existing corp. continues-

 

 

 

 

 

 

100% of stock purchased by another corp.

R

N

R

N

R

 

controlling interest purchased by

indiv. or another businessB

R

N

R

N

R

 

two wholly-owned subsidiaries of parent

corp. are merged with no change in

name, officers, or responsible R.Ph.sC

R

N

R

N

R

 

new corp. created to own and operate sites

with no change in dba or responsible R.Ph.sD

R

N

R

N

R

 

new limited partnership created to own

and operate sites with no change in

dba or responsible R.Ph.sE

R

N

R

N

R

 

CHANGE OF NAME - dba

R

N

R

N

R

 

CHANGE OF ADDRESSF

R

N

R

N

R

 

CHANGE OF CATEGORY (any distributor or satellite)

R

N

R

N

R

 

EMERGENCY MEDICAL SYSTEMS

 

 

 

 

 

 

Add units (HQ / satellites)

Y/N

N

R

N

N

Y/N

Add satellites

 R2

N

R

N

N

 R4

Add/delete drugs; no change in category

(new protocol; new addendums)

N

N

N

N

N

R

Changes name of headquarters

R

N

R

N

R

R

Changes name of satellite

 R3

N

R

N

N

 R4

Changes address of satellite

 R3

N

R

N

N

 R4

Changes protocol (no change in drugs)

N

N

N

N

N

N

Changes address of headquarters

 R5

N

R

N

R

 R5

 

 

R--Required        Y--Yes        N--No

A--Added 04/25/96 By Resolution

B--Controlling Interest = 15% or more

  of the stock in a corp.

C--Added 10/15/83 By Resolution

D--Added 12/02/86 By Resolution

E--Added 03/06/00 By Resolution

F--Requires inspection of new location

1--If new license issued, old license

  must be returned

2--For new satellite(s)

3--For satellite

4--For satellite & headquarters

5--All

 

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

 

RES. 2000-128   Mr. Winsley presented an invoice from the National Association of Boards of Pharmacy (NABP) for the annual dues of $250.  Ms. Adelman moved that the Board authorize the payment of the NABP annual dues.  The motion was seconded by Ms. Eastman and approved by the Board (Aye-7/Nay-0).

 

Ms. Abele reported that the Nursing Board Formulary Committee was not due to meet until April.  Mr. Benedict reported that he had not met with the Medical Board’s Prescribing Committee since the last Board meeting.

  4:05 p.m.

The Board discussed the proposed Minutes of the February 7, 8, 9, 2000 and the February 21, 2000 meetings.  After discussion, Ms. Abele moved that the Minutes be approved as amended.  The motion was seconded by Ms. Eastman and approved by the Board (Aye-7/Nay-0).

  4:16 p.m.

The Board meeting recessed until Tuesday, March 7, 2000.

 

 

TUESDAY, March 7, 2000

 

  9:06 a.m.   ROLL CALL

 

The State Board of Pharmacy convened in Room 1914, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio with the following members present:

 

Robert B. Cavendish, R.Ph. (President); Diane C. Adelman, R.Ph. (Vice-President); Ann D. Abele, R.Ph.; Suzanne R. Eastman, R.Ph.; Robert P. Giacalone, R.Ph.; Lawrence J. Kost, R.Ph.; and Nicholas R. Repke, Public Member.

 

RES. 2000-129   Mr. Winsley presented the applications from two individuals wishing to be approved by the Board as Approved Providers of Continuing Pharmacy Education pursuant to Rule 4729-7-05 of the Administrative Code.  After discussion, Ms. Eastman moved that the Board approve the following as Approved Providers of Continuing Pharmacy Education:

 

Kiki Eley, Select Seminars; Akron

Clinton Memorial Hospital Pharmacy; Wilmington

 

The motion was seconded by Mrs. Adelman and approved by the Board (Aye-6/Nay-0).

  9:15 a.m.

Mr. Littlejohn arrived and joined the meeting.

 

The Board then discussed a document provided by the Pharmacists’ Rehabilitation Organization (PRO) regarding their change to a new laboratory for urine testing.  While there were no items requiring official Board action, there were several issues raised by the document that needed further clarification.  Mr. Benedict was instructed to discuss these issues with a representative of PRO.

  9:24 a.m.

RES. 2000-130   Mr. Benedict then presented requests from two pharmacists wishing to serve as responsible pharmacist at more than one location and asking for a waiver from the requirements of Rule 4729-5-11(A).  After discussion, Ms. Abele moved that the request from Douglas Theuring be approved for the following two locations for one year:

 

Elmwood Place Pharmacy (02-0149650)

Elmwood Institutional Pharmacy (02-0917250)

 

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

 

RES. 2000-131   Ms. Abele then moved that the request from Matthew Buderer be approved for the following two locations for 90 days:

 

Buderer Drug Company; Sandusky (02-1106900)

Buderer Drug Company; Perrysburg (02-1198400)

 

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

10:10 a.m.

The Board was joined by Robert Cole, Compliance Supervisor, and David Rowland, Legal Affairs Administrator, for a discussion of items not requiring official Board action.

10:48 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 Newton R. Standen, R.Ph., Medina, Ohio.

10:57 a.m.

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

  1:00 p.m.

RES. 2000-132   All of the Board members except Mrs. Neuber convened in Room 1919 for the purpose of meeting with the candidates for licensure by reciprocity.  Following presentations by Board members and self-introductions by the candidates for licensure by reciprocity, Mrs. Adelman moved that the Board approve the following candidates for licensure.  The motion was seconded by Ms. Eastman and approved by the Board (Aye-7/Nay-0).

 

CYNTHIA OWENS ANTOL

NORTH CAROLINA

ANGEL KALLAH ASLO

NEVADA

JAMES DANIEL DEFAZIO

PENNSYLVANIA

LANA MARIE DELONG

INDIANA

EUGENIA NIKKI FRANGOS-MAKRICOSTAS

WEST VIRGINIA

GREGORY ALLAN LOW

VERMONT

GEORGE FRANCIS MELITA

NEW YORK

KATRAGADDA  MORTALA

NEW JERSEY

MARY PATRICIA PETRILLO

MICHIGAN

SUSAN MICHELE WETZEL

WEST VIRGINIA

  1:26 p.m.

The Board reconvened in Room 1914 to continue with the Board meeting.  Ms. Abele 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. Adelman and a roll call vote was conducted by President Cavendish as follows: Abele-Yes, Adelman-Yes, Eastman-Yes, Giacalone-Yes, Littlejohn-Yes, Kost-Yes,  and Repke-Yes.

  1:38 p.m.

RES. 2000-133   The Executive Session ended and the meeting was opened to the public.  Ms. Abele moved that the Board adopt the following Order in the matter of Newton R. Standen, R.Ph.:

 

ORDER OF THE STATE BOARD OF PHARMACY

(Docket No. D-991207-036)

 

In The Matter Of:

 

NEWTON R. STANDEN. R.Ph.

3509 Marks Road

Medina, Ohio  44258

(R.Ph. No. 03-2-06815)

 

INTRODUCTION

 

THE MATTER OF NEWTON R. STANDEN CAME TO HEARING ON MARCH 7, 2000, BEFORE THE FOLLOWING MEMBERS OF THE BOARD: ROBERT B. CAVENDISH, R.Ph. (presiding); ANN D. ABELE, R.Ph.; DIANE C. ADELMAN, R.Ph.; SUZANNE R. EASTMAN, R.Ph.; ROBERT P. GIACALONE, R.Ph.; LAWRENCE J. KOST, R.Ph.; AMONTE B. LITTLEJOHN, R.Ph.; AND NICHOLAS R. REPKE, PUBLIC MEMBER.

 

NEWTON R. STANDEN WAS NOT REPRESENTED BY COUNSEL, AND THE STATE OF OHIO WAS REPRESENTED BY SALLY ANN STEUK, ASSISTANT ATTORNEY GENERAL.

 

SUMMARY OF EVIDENCE

 

(A)    Testimony

 

State's Witnesses:

 

(1)    Paul J. Kover, R.Ph., Ohio State Board of Pharmacy

 

Respondent's Witnesses:

 

(1)    Newton R. Standen, Respondent

 

(B)    Exhibits

 

State's Exhibits:

 

(1)    Exhibit 1—Copy of four-page Order of the State Board of Pharmacy, Docket No. D-990323-042, effective June 17, 1999.

(2)    Exhibit 1A—Copy of letter from Joseph M. Lahovich, R.Ph., dated November 22, 1999, with attached one-page copy of the same letter and a check.

(3)    Exhibit 1B—Copy of Hearing Request letter dated December 2, 1999.

(4)    Exhibit 1C—Copy of Hearing Schedule letter dated December 7, 1999.

(5)    Exhibit 1D—Copy of three-page Notice of Opportunity for Hearing letter dated March 23, 1999.

(6)    Exhibit 1E—Copy of letter from Newton R. Standen dated April 2, 1999, with attached copy of Page 2 of Notice of Opportunity.

(7)    Exhibit 1F—Copy of Pharmacist File Front Sheet of Newton Reese Standen showing original date of registration as July 31, 1958, and two-page copy of Renewal Application for Pharmacist License, No. 03-2-06815, for a license to practice pharmacy in Ohio from September 15, 1998, to September 15, 1999, of Newton R. Standen dated August 7, 1998.

(8)    Exhibit 2—Copy of eight-page transcript of interview of Newton R. Standen by Pharmacy Board agents Paul J. Kover and Carl N. Frost on June 22, 1998.

(9)    Exhibit 3—Copy of two-page memo from Joseph M. Lahovich dated May 4, 1998.

(10)  Exhibit 4—Copy of Signature Log Verification report from Acme Pharmacy #72 for the period March 7, 1998, through March 25, 1998.

(11)  Exhibit 5—Two-page copy of Security Office report of the Fred W. Albrecht Grocery Company dated March 26, 1998, signed by Newton R. Standen and dated March 25, 1998.

(12)  Exhibit 6—Copy of handwritten statement of Newton R. Standen dated March 25, 1998.

(13)  Exhibit 7—Copy of handwritten statement of Newton R. Standen dated June 22, 1998.

(14)  Exhibit 8—Copy of Journal Entry in the Summit County Court of Common Pleas, State of Ohio vs. Newton Reese Standen, Case No. CR 98-03-0802, dated November 24, 1998.

(15)  Exhibit 9—Copy of Board agent documentation of a conversation with Detective Adrian D. Johnson of the Akron Police Department.

 

Respondent's Exhibits:

 

(1)    None

 

ACTION OF THE BOARD

 

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 hereby denies the reinstatement petition of Newton R. Standen.

 

Pursuant to Rule 4729-9-01(F) of the Ohio Administrative Code, Newton R. Standen may not be employed by or work in a facility licensed by the State Board of Pharmacy to possess or distribute dangerous drugs during suspension.

 

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

MOTION CARRIED.

SO ORDERED.

 

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

  2:05 p.m.

The Board was joined by Assistant Attorney General Sally Ann Steuk for the purpose of conducting an adjudication hearing in accordance with Ohio Revised Code Chapters 119. and 4729. in the matter of Jay Stephan Belcher, R.Ph., Cincinnati, Ohio.

  3:31 p.m.

The hearing concluded and the record was closed.

  3:40 p.m.

Ms. Abele 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. Adelman and a roll call vote was conducted by President Cavendish as follows: Abele-Yes, Adelman-Yes, Eastman-Yes, Giacalone-Yes, Littlejohn-Yes, Kost-Yes, and Repke-Yes.

  3:45 p.m.

RES. 2000-134   The Executive Session ended and the meeting was opened to the public.  Ms. Abele moved that the Board adopt the following Order in the matter of Jay Stephan Belcher, R.Ph.:

 

ORDER OF THE STATE BOARD OF PHARMACY

(Docket No. D-000208-043)

 

In The Matter Of:

 

JAY STEPHAN BELCHER, R.Ph.

1046 Westchester Way

Cincinnati, Ohio 45244

(R.Ph. No. 03-1-17435)

 

INTRODUCTION

 

THE MATTER OF JAY STEPHAN BELCHER CAME TO HEARING ON MARCH 7, 2000, BEFORE THE FOLLOWING MEMBERS OF THE BOARD: ROBERT B. CAVENDISH, R.Ph. (presiding); ANN D. ABELE, R.Ph.; DIANE C. ADELMAN, R.Ph.; SUZANNE R. EASTMAN, R.Ph.; ROBERT P. GIACALONE, R.Ph.; LAWRENCE J. KOST, R.Ph.; AMONTE B. LITTLEJOHN, R.Ph.; AND NICHOLAS R. REPKE, PUBLIC MEMBER.

 

JAY STEPHAN BELCHER WAS REPRESENTED BY DAVID L. KERR, AND THE STATE OF OHIO WAS REPRESENTED BY SALLY ANN STEUK, ASSISTANT ATTORNEY GENERAL.

 

SUMMARY OF EVIDENCE

 

(A)    Testimony

 

State's Witnesses:

 

(1)    Joseph Holliday, Ohio State Board of Pharmacy

 

Respondent's Witnesses:

 

(1)    Jay Stephan Belcher, Respondent

 

(B)    Exhibits

 

State's Exhibits:

 

(1)    Exhibit 1--Copy of four-page Summary Suspension Order/Notice of Opportunity for Hearing letter dated February 8, 2000.

(2)    Exhibit 1A--Hearing Request letter, not dated, received February 16, 2000; and Statement of Authorization of Jay Belcher.

(3)    Exhibit 1B--Copy of Hearing Schedule letter dated February 17, 2000.

(4)    Exhibit 1C--Copy of Pharmacist File Front Sheet of Jay Stephan Belcher showing original date of registration as July 29, 1988; and two-page Renewal Application for Pharmacist License, No. 03-1-17435, for a License to Practice Pharmacy in Ohio from September 15, 1999, to September 15, 2000, of Jay Stephan Belcher dated July 6, 1999.

(5)    Exhibit 2--Copies of five pages of statements of Jay S. Belcher dated December 30, 1999.

(6)    Exhibit 3--Copy of three-page Supplemental/Incident Report of Lisa L. Hearn dated December 30, 1999, regarding Jay S. Belcher, Case No. A99-157-0235.

(7)    Exhibit 4--Copies of six pages consisting of the following: Meijer Store #157 Audit for Item 420169; two-page Meijer Store #157 Misc. Inventory Adjustments for Random Count for Product UPCs 0-51285-60202 and 3-02282-00310, report dated December 30, 1999; and three-page handwritten list of dates including October 31, through December 28, and people who worked on those dates.

(8)    Exhibit 4A--Copy of Meijer Loss Prevention Dept. Personal History Form of Jay S. Belcher dated December 30, 1999.

(9)    Exhibit 5--Copy of handwritten statement of Jay Belcher dated December 30, 1999.

(10)  Exhibit 6--Copy of six-page Miami Township Police Department Ohio Uniform Incident Report regarding Theft from Meijer’s, 1082 Meijer Dr., Milford, Ohio , dated December 30, 1999, and January 4, 2000.

(11)  Exhibit 7--Copy of letter from Margaret A. Olman dated February 4, 2000.

 

Respondent's Exhibits:

 

(1)    Copy of three-page Status of the Case regarding Jay Stephan Belcher submitted by David L. Kerr on March 7, 2000.

(2)    Exhibit 1--Copy of letter from Roberto Soria dated February 28, 2000.

(3)    Exhibit 2--Copy of letter from Linda Castle dated February 24, 2000.

(4)    Exhibit 3--Two-page copy of Pharmacists Rehabilitation Organization, Inc. Pharmacist’s Recovery Contract of Jay Belcher dated February 15, 2000.

(5)    Exhibit 4--Two-page copy of front covers of eight study materials as follows: Chemical Dependency: An Acceptable Disease; How To Get The Most Out Of Group Therapy; A Look At Cross-Addiction; two copies of Relapse And The Addict; When You Go Back To Work; Step 1-The Foundation of Recovery; and Finding Your Strengths.

(6)    Exhibit 4A--Two-page copy of Alcohol and Drug Treatment of Jay S. Belcher dated March 1, 2000.

(7)    Exhibit 5--Copies of four Goos (sic Good) Samaritan Hospital urine drug screen reports of Jay Belcher dated January 6, 2000; January 18, 2000; January 25, 2000; and February 4, 2000.

(8)    Exhibit 6--Two-page copy of AA/NA Meeting Verification Calendar for January/February 2000, and February/March 2000.

(9)    Exhibit 7--Two-page copy of list of NA Meetings for Winter 1999 held Monday through Friday.

(10)  Exhibit 7A--Copy of Record of Meeting Attendance of Jay Belcher dated from February 6, 2000, through February 28, 2000.

(11)  Exhibit 8--Two-page copy of brochure for Eastside Center, Batavia, Ohio, AA and Al-Anon Meeting Schedule and Information.

(12)  Exhibit 9--Bethesda Hospital Medical Records of Jay S. Belcher as follows: Discharge Instructions of Jay Belcher dated January 3, 2000; Copy of Explanation of Patients’ Financial Responsibilities dated December 31, 1999; Discharge Instructions regarding Home Medication, not dated; Special Chemical Dependency Benefit Conditions Regarding Financial Responsibilities dated January 4, 2000; Patients’ Responsibilities dated January 4, 2000; Patients’ Rights dated January 4, 2000; Statement of Payment Responsibilities Related To Insurance Coverage dated January 4, 2000; Consent to Treat and Coordinate Care dated January 4, 2000; Rights and Responsibilities as a Patient; Oak Outpatient Services Schedule, Intervention Plan Objectives 2, 7, and 12; and three-page Relapse Prevention.

(13)  Exhibit 10--Copies of the following: Stress Scale dated January 26, 2000; Listing of “Symptoms of Stress”, “Symptoms of Post-Acute Withdrawal Syndrome”; and “To Reduce the Intensity of Stress and PAWS”; pages 3 through 6 of Leisure Time Planning Exer.-Cont. Recreation is Where You Find It.

(14)  Exhibit 11--Copy of patient prescription information for Meijer #148 prescription number 6696078.

(15)  Exhibit 12--Copy of nineteen 12 Step Reaction Sheets of Jay Belcher dated from January 14, 2000, through February 28, 2000.

(16)  Exhibit 13--Copy of letter from The Rev. Roger S. Greene dated February 26, 2000.

(17)  Exhibit 14--Copy of letter from Marie E. Belcher dated March 2, 2000.

 

FINDINGS OF FACT

 

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

 

(1)    Records of the State Board of Pharmacy indicate that Jay Stephan Belcher was originally licensed in the state of Ohio on July 29, 1988, pursuant to examination, and on February 8, 2000, Jay Stephan Belcher’s license was summarily suspended pursuant to Divisions (A) and (B) of Section 3719.121 of the Ohio Revised Code.

 

(2)    Jay Stephan Belcher is addicted to liquor or drugs or impaired physically or mentally to such a degree as to render him unfit to practice pharmacy, to wit: Jay Stephan Belcher admitted to stealing drugs from his employers for personal use; in his estimation, Jay Stephan Belcher has stolen approximately 35 stock bottles containing 100 unit doses of acetaminophen #4 with codeine from August, 1999, to December, 1999; Jay Stephan Belcher has ingested 10-18 Acetaminophen #4 with codeine per day; and, Jay Stephan Belcher admitted having a codeine addiction for approximately 8-9 years.  Such conduct indicates that Jay Stephan Belcher falls within the ambit of Sections 3719.121(A), 3719.121(B), and 4729.16(A)(3) of the Ohio Revised Code.

 

(3)    Jay Stephan Belcher did, from on or about August, 1999, to December, 1999, with purpose to deprive, knowingly obtain or exert control over controlled substances, the property of Meijer Pharmacy #157 in Milford, Ohio beyond the express or implied consent of the owner, to wit: Jay Stephan Belcher stole 3,310 unit doses of acetaminophen #4 with codeine from his employer.  Such conduct is in violation of Section 2913.02 of the Ohio Revised Code. 

 

(4)    Jay Stephan Belcher did, on or about December 30, 1999, with purpose to deprive, knowingly obtain or exert control over controlled substances, the property of Meijer Pharmacy #157 in Milford, Ohio beyond the express or implied consent of the owner, to wit: Jay Stephan Belcher stole a stock bottle containing 100 unit doses of acetamino­phen/codeine #4 from his employer.  Such conduct is in violation of Section 2913.02 of the Ohio Revised Code. 

 

CONCLUSIONS OF LAW

 

(1)    Upon consideration of the record as a whole, the State Board of Pharmacy concludes that paragraphs (3) and (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.

 

(2)    Upon consideration of the record as a whole, the State Board of Pharmacy concludes that paragraph (2) of the Findings of Fact constitutes being addicted to or abusing liquor or drugs or impaired physically or mentally to such a degree as to render him unfit to practice pharmacy as provided in Division (A)(3) of Section 4729.16 of the Ohio Revised Code.

 

ACTION OF THE BOARD

 

Pursuant to Section 3719.121 of the Ohio Revised Code, the State Board of Pharmacy hereby removes the Summary Suspension Order issued February 8, 2000, to Jay Stephan Belcher.

 

Pursuant to Section 4729.16 of the Ohio Revised Code, and on the basis of the Findings of Fact and Conclusions of Law set forth above, the State Board of Pharmacy hereby suspends indefinitely the pharmacist identification card, No. 03-1-17435, held by Jay Stephan Belcher and such suspension is effective as of the date of the mailing of this Order.

 

(A)    Jay Stephan Belcher, pursuant to Rule 4729-9-01(F) of the Ohio Administrative Code, may not be employed by or work in a facility licensed by the Board of Pharmacy to possess or distribute dangerous drugs during such period of suspension.

 

(B)    Jay Stephan Belcher, pursuant to Section 4729.16(B) of the Ohio Revised Code, must return the identification card and wall certificate to the office of the State Board of Pharmacy within ten days after receipt of this Order.  The identification card and wall certificate should be forwarded by certified mail, return receipt requested.

 

Further, April 1, 2001, or thereafter, the Board will consider any petition filed by Jay Stephan Belcher for a hearing, pursuant to Ohio Revised Code Chapter 119., for reinstatement.  The Board will only consider reinstatement of the license to practice pharmacy in Ohio if the following conditions have been met:

 

(A)    Jay Stephan Belcher must enter into a contract, after the effective date of this Order, with an Ohio Department of Alcohol and Drug Addiction Services (ODADAS) treatment provider or a treatment provider acceptable to the Board for a period of not less than five years and, upon signing, submit a copy of the contract to the Board office.  The contract must provide:

 

(1)    Random, observed urine drug screens shall be conducted at least once each month.

 

(a)    The urine sample must be given within twelve hours of notification.  The urine screen must include testing for creatinine or specific gravity of the sample as the dilutional standard.

 

(b)    Alcohol must be added to the standard urine drug screen.  A Breathalyzer may be used to test for alcohol, but the test must be conducted by an appropriately certified individual within twelve hours of notification.

 

(c)    Results of all drug and alcohol screens must be negative.  Any positive results, including those which may have resulted from ingestion of food, but excluding false positives which resulted from medication legitimately prescribed, indicates a violation of the contract.

 

(2)    Regular attendance, a minimum of three times per week, at an Alcoholics Anonymous, Narcotics Anonymous, and/or similar support group meeting is required.

 

(3)    The program shall immediately report to the Ohio Board of Pharmacy any violations of the contract and/or lack of cooperation.

 

(B)    Jay Stephan Belcher must provide, at the reinstatement petition hearing, documentation of the following:

 

(1)    Compliance with the contract required in paragraph (A) above (e.g.-copies of all urine screen reports, copies of meeting attendance records, treatment program reports, etc.);

 

(2)    Compliance with the continuing pharmacy education requirements as set forth in Chapter 4729-7 of the Ohio Administrative Code (if applicable);

 

(3)    Evidence of having made restitution to all employers.

 

(4)    Compliance with the terms of this Order.

 

(C)    If reinstatement is not accomplished within three years of the effective date of this Order, Jay Stephan Belcher must successfully complete the NAPLEX examination or an equivalent examination approved by the Board.

 

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

MOTION CARRIED.

SO ORDERED.

 

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

  4:46 p.m.

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

 

PER DIEM

3/6

3/7

Total

Abele

1

1

2

Adelman

1

1

2

Cavendish

1

1

2

Eastman

1

1

2

Giacalone

1

1

2

Littlejohn

1

1

2

Kost

1

1

2

Neuber

-

-

0

Repke

1

1

2

 

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

  4:47 p.m.

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

 

  /s/                  Robert B. Cavendish                                   /d/       4-5-00         

                  Robert B. Cavendish, President                                           Date

 

                              /s/                      W  T  Winsley                          

                                    William T. Winsley, Executive Director