State Board of Pharmacy; 77 South High Street, Room 1702; Columbus, Ohio 43215-6126

Tel: 614/466-4143                     Fax: 614/752-4836                  Eml:




~~ MAY 2002 ~~



The Ohio State Board of Pharmacy News is published by the Ohio State Board of Pharmacy and the National Association of Boards of Pharmacy Foundation, Inc. to promote voluntary compliance of pharmacy and drug law.  The opinions and views expressed in this publication do not necessarily reflect the official views, opinions, or policies of the Foundation or the Board unless expressly so stated.

William T. Winsley, MS, RPh - State News Editor

Carmen A. Catizone, MS, RPh - National News Editor & Executive Editor

Courtney M. Karzen - Editorial Manager



State News Section



Continuing Pharmacy Education Changes

As of February 1, 2002, the Ohio State Board of Pharmacy’s rules on continuing pharmacy edu­cation (CPE) have changed.  It is still necessary for pharmacists to report six CEUs (60 hours) of CPE over a three-year reporting period, but the only required subject is 0.3 CEUs (three hours) of Board-approved juris­pru­dence.  The Board agreed to eliminate the requirement that 45 of the 60 hours con­sist of patient-care (01 or 02) coursework.  Beginning with those pharmacists whose license numbers begin with 03-2 and who report this year, it will be necessary to show 5.7 CEUs (57 hours) of CPE in any category (01, 02, 03, or 04) and 0.3 CEUs (3 hours) in Board-approved jurisprudence.  Remem­ber that, as an alternative to the 57 hours, a pharmacist may submit proof of certification in a Board-approved pharmacy practice spe­cific specialty.

In addition to changing the reporting requirements, the Board is also in the process of changing the time that CPE is reported by pharmacists.  Due to the fact that we will soon be required to have an out­side vendor handle our renewal forms and money instead of the state treasurer’s office, we are sepa­rating the CPE reporting from the pocket identification card renewals.  Beginning in 2004 with those phar­macists whose license numbers begin with 03-1, pharmacists will be required to report their CPE during the spring, prior to the time for renewal of the pocket identification card.  We are phasing in the earlier reporting time by making it voluntary for those pharmacists who report this year (03-2) and those who report in 2003 (03-3).  It will be mandatory in 2004 (03-1).  Those pharmacists who have to report CPE this year have already received a CPE report form along with a letter of explanation.  If the CPE report form is returned to the Board office prior to May 15, 2002, then the pharmacist pocket identification card renewal form will be sent without any CPE paperwork.  Since the outside vendor will charge us for any extra paper that they have to handle, early reporting will help the Board save money.  At the time of the writing of this article, we have already received a number of completed CPE report forms back from pharmacists.  Our thanks go out to them and to others who will meet the May 15, 2002 cutoff date.  For those pharmacists who will report in 2004 (03-1), please be aware that you will be required to report your CPE no later than May 1, 2004.  For that reporting period, you will be able to use certificates dated on or after March 1, 2001 that were not used for the CPE reporting in 2001.


Disciplinary Actions

Anyone having a question regarding the license status of a particular practitioner, nurse, phar­ma­cist, pharmacy intern, or dangerous drug distributor in Ohio should con­tact the appropriate licensing board.  The Web sites listed below may include disciplinary actions for their respective licensees.

State Dental Board -- 614/466-2580,

State Medical Board -- 614/466-3934,

State Nursing Board -- 614/466-3947,

State Optometry Board -- 614/466-5115,

State Veterinary Medical Board -- 614/644-5281,

Drug Enforcement Administration -- 800/230-6844;

State Pharmacy Board --

The disciplinary actions listed below include only those where the individual’s license to practice has been suspended, revoked, or restricted, and does not include any other actions taken by the Board.  All actions may be seen in the minutes, which are posted on the Board's Web site, then click on "Board Minutes."

Orders of the Board:

Robert A. Berkowitz, R.Ph.; Lyndhurst - License suspended indefinitely March 7, 2002 and, while suspended, may not be employed by or work in a facility licensed by the Board.

Lawrence E. Broome, R.Ph.; Wellington - License revoked February 8, 2002.

Kevin Chakos, R.Ph.; Pittsburgh, PA - License suspended indefinitely December 10, 2001 and, while suspended, may not be employed by or work in a facility licensed by the Board.

Debra Lynn Cooper, R.Ph.; Lexington - License suspended indefinitely November 7, 2001 and, while suspended, may not be employed by or work in a facility licensed by the Board.

Richard D. Dudek, R.Ph.; Warren - License suspended ten years January 11, 2002 and, while sus­pended, may not be employed by or work in a facility licensed by the Board.  The Board will stay the last nine years of the suspension and place Mr. Dudek on probation if he passes the MPJE within the first year of suspension.  Upon reinstatement, Mr. Dudek may not serve as a preceptor or train pharmacy interns or serve as a responsible pharmacist while on pro­bation.

Foster D. Farone, R.Ph.; Mount Crawford, VA - License revoked March 7, 2002.

Joseph Neil Gioiello, R.Ph.; Warren - License reinstated November 19, 2001; Placed on pro­ba­tion five years and may not serve as a preceptor or train pharmacy interns, serve as a re­spon­sible phar­ma­cist, or destroy or witness the destruction of controlled substances while on pro­ba­tion.

Ralph G. Homer, R.Ph.; Olmsted Township - License suspended indefinitely January 11, 2002 and, while suspended, may not be employed by or work in a facility licensed by the Board.

Ojinika I. Mora, R.Ph.; Columbus - License suspended indefinitely November 7, 2001 and, while sus­pended, may not be employed by or work in a facility licensed by the Board.  License rein­stated December 17, 2001; May not serve as a preceptor or train pharmacy interns, or serve as a re­spon­sible pharmacist for two years.

George L. Plataz, R.Ph.; Willoughby - License suspended indefinitely February 8, 2002 and, while suspended, may not be employed by or work in a facility licensed by the Board.

Gerald Poorbaugh, R.Ph.; Sebring - License suspended indefinitely November 7, 2001 and, while sus­pended, may not be employed by or work in a facility licensed by the Board.  License re­in­stated January 23, 2002; Probation extended until December 16, 2002 and may not serve as a preceptor or train pharmacy interns while on probation.

Raleigh L. Smith, R.Ph.; Waldo - License reinstated October 11, 2001; Placed on probation five years and may not serve as a preceptor or train pharmacy interns, serve as a responsible phar­macist, or destroy or witness the destruction of controlled substances while on pro­ba­tion.

Michelle M. Solnosky, R.Ph.; Euclid - License suspended indefinitely February 8, 2002 and, while suspended, may not be employed by or work in a facility licensed by the Board.

David W. White, R.Ph.; Cincinnati - License suspended indefinitely November 7, 2001 and, while suspended, may not be employed by or work in a facility licensed by the Board.

Settlement Agreements:

Crystal Edward White, R.Ph.; Warrensville Heights - License and registration permanently surrendered March 5, 2002.

Summary Suspensions:  [Sec. 3719.121 of the Revised Code]

Robert A. Berkowitz, R.Ph.; Lyndhurst - December 5, 2001.

Alvin Dorfman, R.Ph.; Cincinnati - December 6, 2001.

Patricia Ann Flack, R.Ph.; Springfield - December 6, 2001.

Michael M. Fraulini, R.Ph.; Portsmouth - March 7, 2002.

Karen S. Frederick, R.Ph.; Fremont - January 10, 2002.

Bradley R. Laboe, R.Ph.; Maumee - December 5, 2001.

Michael Lee Lacy, R.Ph.; Westerville - December 5, 2001.

Gregory Scott Mills, R.Ph.; Grove City - March 26, 2002.

Mark Alan Moore, R.Ph.; Riverside - March 5, 2002.

John R. Tomko, R.Ph.; Hubbard - March 7, 2002.

Dale R. Vaughn, R.Ph.; Warren - February 22, 2002.

Crystal Edward White, R.Ph.; Warrensville Heights - January 31, 2001.




National News Section


Applicability of the contents of articles in the National Pharmacy Compliance News to a particular state or juris­diction should not be assumed and can only be ascertained by examining the law of such state or jurisdiction.


DEA Issues Guidance on Dispensing Controlled Substances to Assist Suicide

The US Drug Enforcement Administration (DEA) issued a guidance notice in the November 9, 2001 Fed­eral Register stating that the Attorney General determined that assisting suicide is not a legitimate medical purpose within the meaning of 21 CFR 1306.04 (2001) and that prescribing, dis­pens­ing, or administering federally controlled substances to assist suicide violates the Controlled Substances Act. According to the notice, such conduct by a physician registered to dispense con­trolled substances may render his registra­tion inconsistent with the public interest and subject to possible suspension or revocation. The Attorney General’s conclusion applies regardless of whether state law authorizes or per­mits such conduct by prac­titioners or others and regardless of the con­di­tion of the person whose suicide is assisted. This notice may be found at the DEA’s Web site at

For further information contact Patricia M. Good, Chief, Liaison and Policy Section, Office of Di­ver­sion Control, Drug Enforcement Administration, Washington, DC 20537, telephone 202/307-7297.


FDA Issues Guidance on Potassium Iodide as a Thyroid Blocking Agent

in Radiation Emergencies

The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) issued a guidance to other federal agencies in November 2001 that recognizes potassium iodide (KI) as a thyroid blocking agent in radiation emergencies.

Based upon thorough research, FDA has proposed lower radioactive exposure thresholds for KI pro­phylaxis as well as lower doses of KI for neonates, infants, and children than it recom­mended in 1982. FDA continues to recommend that radiation emergency response plans include, in the event of a radiation emergency, provisions for informing the public about the magnitude of the radiation hazard, about the manner of use of KI and its potential benefits and risks, and for medical contact, reporting, and assistance systems. FDA also emphasizes that emergency re­sponse plans and any systems for ensuring availability of KI to the public should recognize the critical importance of KI administration in advance of exposure to radioiodine.

As in the past, FDA continues to work in an ongoing fashion with manufacturers of KI to ensure that high-quality, safe, and effective KI products are available for purchase by consumers as well as by state and local governments wishing to establish stores for emergency distribution. FDA empha­sizes that the use of KI should be an adjunct to evacuation (itself not always feasible), shel­ter­ing, and control of foodstuffs. The guidance may be viewed in its entirety  on the FDA’s Web site at


USP Launches Dietary Supplement Verification Program

The US Pharmacopeia (USP) recently announced the availability of its Dietary Supplement Veri­fi­ca­tion Program (DSVP). Developed in response to the USP Convention membership’s resolutions in 1995 and 2000, urging the USP to develop standards and analytical methods for dietary sup­ple­ments, and, in par­ti­cular, botanicals, the USP will work directly with dietary supplement companies to verify the in­tegrity of those they submit to USP.

Each product will be evaluated on the following criteria:


Quality control and manufacturing data review;


Laboratory evaluation of product samples and regular monitoring; and


Evaluation of manufacturers’ quality systems by means of an audit.

Based on USP’s assessment of the manufacturer’s capability to produce a dietary supplement and testing to USP standards, USP will issue a certification mark that the manufacturer can use on the die­tary supplement container label. According to USP, the presence of this mark indicates that the pro­duct con­tains the dietary supplement ingredient in the designated amount, meets acceptable limits of unde­sirable elements, and is manufactured appropriately.

While the DSVP complements the US Food and Drug Administration’s regulation of dietary sup­ple­ments under the Dietary Supplement Health and Education Act of 1994 (DSHEA), USP notes that it does not address health or other claims provided under the DSHEA. The USP Council of Experts’ Die­tary Sup­ple­ment Information Expert Committee will initially review all products submitted for veri­fi­ca­tion in instances where safety concerns have been raised.

USP anticipates that the DSVP mark will offer patients a basis for confidence in the dietary sup­ple­ment they use and that health care professionals will have the assurance that products bearing the dis­tinc­tive mark and the words “USP Verified” have satisfied rigorous scientific criteria and assess­ments.

For more information about the DSVP, visit the USP’s Web site at


Inappropriate Designation of Dosage Form is a Common Source of Error

This is the first of a new feature about medication errors written by the Institute for Safe Medication Prac­tices (ISMP). ISMP is an independent nonprofit agency that works closely with US Pharmacopeia (USP) and Food and Drug Administration (FDA) in analyzing medication errors, near misses, and potentially hazardous conditions as reported by pharmacists and other practitioners. ISMP then makes appropriate contacts with companies and regulators, gathers expert opinion about prevention measures, then publishes its recom­men­dations. If you would like to report a problem confidentially to these organizations, go to the ISMP Web site ( for links with USP, ISMP and FDA. Or call 1-800/23-ERROR to report directly to the USP-ISMP Medication Errors Report­ing Program. ISMP address: 1800 Byberry Road, Huntingdon Valley, PA 19006. Phone 215/947- 7797. E-mail:

Confusion seems to reign whenever a medication is available in oral dosage forms with dif­fer­ent re­lease rates. The situation is worse when there are two or more “delayed” release formulations for the same product. We recently heard about four cases where community pharmacists dispensed METADATE ER instead of METADATE CD. Both are methylphenidate hydrochloride extended-release, but they are not substitutable. The CD product is a once-a-day capsule with biphasic release. There is an initial rapid release of methylphenidate, then a continuous release phase, resulting in school-day-long control of attention deficit hyperactivity disorder (ADHD) symptoms. The ER product is a tablet given two to three times a day. It may be titrated to remove the need for midday dosing. Each of the pharmacists involved in the error were not aware that the Metadate CD product existed.

Recently, Novartis received FDA approval for another once-a-day methylphenidate, RITALIN LA.  This will be available on the market along with RITALIN SR, another sustained release dosage form.  Thus, con­fu­sion can be expected between these two formulations. Last year we also learned about similar con­fu­sion between Abbott’s DEPAKOTE ER (divalproex sodium extended release) and DEPAKOTE (divalproex sodium delayed release).

To make matters worse, it is common for physicians to prescribe an extended release product without the appropriate name or suffix. Also, some products have numerous suffixes to differentiate formulations of the same drug. For example, suffixes for various diltiazem products include SR, CD, XR, and XT. As one colleague recently stated, “Between all the generics and brands trying to differen­tiate themselves, it is all but impossible to keep from making mistakes.”

Nomenclature standards need to be established to allay confusion between various formulations of the same drug. Perhaps a unique brand name might be needed to designate a different for­mu­la­tion pro­perty, as was done with NEORAL (cyclosporine modified) and SANDIMMUNE (cyclosporine).

Meanwhile, carefully select new medications with the knowledge that confusion between different formulations and suffixes is likely. Build alerts into computer systems and mark drug containers to warn pharmacists and technicians about the differences. Some pharmacists design computer mne­monics to separate the different formulations on their computer screens.

Keep in mind that prescriber confusion between the various drug name suffixes has also been reported. New prescriptions for any of these medications may need to be verified. When prescribing one of these medications, physicians should alert patients to possible confusion between the various formulations and suffixes so they can help identify an error before taking the medication when they take the oppor­tun­ity to speak with the pharmacist during counseling. Pharmacists should encourage patients to request such interaction with their physicians.

FDA is aware of these problems and will be examining ways to improve trademark nomenclature. An industry guidance has been promised for later this year.